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Job Description Role and Responsibilities: We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Senior Specialist. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical Candidate (PCC) to registration. This role is a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O will work in collaborative teams with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform primary responsibilities including:<ul><li>Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics</li><li>Developing and executing pharmacokinetics and pharmacodynamics modelling approaches, such as population pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses. </li><li>Perform clinical trial simulations to inform dose selection and go/no-go decisions</li><li>Being or supporting the QP2-I/O Function Lead on oncology development teams.</li><li>Data management and analysis.</li></ul>On the job, working with senior scientists you will develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency interactions. You will also develop leadership skills in areas such as mentoring, managing a program, project, or initiative. In addition to the responsibilities outlined above, Senior Specialists are expected to demonstrate good communication skills, collaborating within QP2-I/O and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact decisions of drug development teams. The ideal candidate is highly collaborative, eager to learn and not intimidated by tough scientific challenges. Excellent communication skills are required including the ability to clearly present scientific data in group settings. Minimum education required: Ph.D. or equivalent degree - OR - a PharmD or equivalent degree with at least 2 years of experience - OR - Masters or equivalent degree with at least 4 years of experience relating to: pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering, where experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia. Required Experience: <ul><li>An educational background in pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering.</li><li>Proficiency in R, NONMEM, Phoenix, MONOLIX or other similar programing language.</li><li>Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics</li><li>Experience in performing population pharmacokinetics and pharmacodynamics analyses</li><li>Professional working proficiency in written and verbal communication.</li><li></li></ul> "This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. Please note that standard commute is (less than) NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 07/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:07/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297290

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Senior Specialist - Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (Remote)

Job Description The Senior AI/ML Data Scientist - Natural Language Processing (NLP) role involves helping to develop and deploy production-grade NLP products for unstructured and semi-structured data from across our company's research and development pipeline. These models and workflows will help solve real-world problems and contribute to Artificial Intelligence and Machine Learning (AI/ML) in therapeutic research and development. Key focus areas will include the scalable deployment of ML and Generative AI approaches (such as Large Language Models, or LLMs) for surfacing insights from proprietary unstructured research data and biomedical literature, as well as developing fit-for-purpose approaches for the likes of text classification, relation extraction, and entity linking. The position is embedded in a cross-disciplinary team of data scientists, bioinformaticians, and engineers that are all focused on using cutting-edge software, AI/ML, and data science techniques to drive drug discovery and development. You enjoy: <ul><li> Building novel tools that enable the discovery, development, and delivery of new therapeutics to patients in need </li><li> Understanding real-world challenges and developing automated data solutions for them </li><li> Opportunities to directly interact with users of your data science, ML , and AI products </li><li> Evaluating, developing, testing, and deploying new techniques for natural language understanding </li><li> Freedom to propose projects that interest you and to collaborate cross-functionally on delivery </li><li> Staying updated on the newest methods in NLP, ML , and generative AI </li><li> Sharing the approaches you implement and their impact with internal company audiences and externally </li></ul> You have : The following are preferred skills and experience , not strict requirements <ul><li> Fluency in Python programming, version control and collaboration with git, environment management (e.g., poetry, conda , docker ), standard Python packages (e.g., pandas, numpy , matplotlib), and at least one ML framework (e.g., pytorch , tensorflow , fairseq ) </li><li> Experience with scalable data engineering frameworks such as Apache Spark and orchestration frameworks such as Airflow , and/or experience with semantic search and retrieval frameworks (e.g., development and benchmarking of embedding model s and retrieval approaches in the context of Retrieval Augmented Generation , RAG) . </li><li> Experience with ML model deployment and operations (e.g., DevOps, MLOps , LLMOps ), including CI/CD workflows and tooling (e.g., Github actions) </li><li> Experience with standard operations on non-relational (e.g., Elasticsearch / Opensearch , MongoDB, Neptune) , relational databases (e.g., PostgreSQL) , and vector databases (e.g., pgvector , E lasticsearch dense vectors ) and deployment of APIs and web applications (e.g., flask, fastAPI , django , or dash) </li><li> ⁠ Working knowledge of statistical learning, such as supervised, unsupervised, and weakly supervised learning, particularly in NLP contexts. </li><li> Working knowledge of NLP and/or Generative AI libraries (e.g., regular expressions, s pacy, langchain ), text annotation tools, and/or semantic frameworks ( e.g. RDF triplestores , property graphs , ontology management). </li><li> A demonstrated ability to engage cross-functional teams and stakeholders, including an eagerness to acquire a level of domain knowledge </li></ul><ul><li> Excellent communication, teamwork, didactic, and leadership skills, including skills for scientific communication (authoring scientific articles and presenting) and guidance and mentorship of junior employees and less experienced collaborators </li></ul> Minimum Requirements : <ul><li> A PhD in data science, AI/ML/LLM engineering, computer science, semantic engineering or a related discipline OR M.S. with 2 years industry experience OR B.S. with 5 years industry experience focused on NLP, data science, AI/ML/LLM engineering, computer science, semantic engineering or a related discipline </li><li> 2 years experience with Python , Spark , or related frameworks in AI, machine learning, data science, data engineering, or similar context </li><li> 1 years experience with Natural Language Processing, Generative AI, or related techniques for machine understanding of natural language (i.e., written text, omics data, or similar). </li></ul> Additional job details: The types of datasets we focus on are both internal (e.g., electronic lab notebooks, safety reports, regulatory documents, clinical results) and external (e.g., public literature and Electronic Medical Records). In addition to new tool development, we often consult with some of our 5 ,000+ stakeholders (scientists, engineers, regulatory liaisons, data scientists, etc.) on their own projects, as well as additional stakeholders from across our multi-national company. We strive to enhance data science , NLP , and AI literacy across these groups. As part of our work, we have opportunities to coauthor presentations, reports, manuscripts, and/or public code releases. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $122,800.00 - $193,300.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management Preferred Skills: Job Posting End Date: 06/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292116

Senior AI/ML Data Scientist, Natural Language Processing (Hybrid)

Job Description The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:<ul><li>Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.</li><li>Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.</li><li>Providing quality advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies </li><li>Building our leadership and functional capability to keep pace with the changing science and regulatory environment.</li><li>Establishing and effective implementation and oversight model to maintain best in industry regulatory compliance.</li></ul>The Vice President Regulatory Affairs, General Medicine is accountable for:<ul><li>Directing and Supervising the General Medicine Therapeutic Area (Regulatory)</li><li>Directing and supervising Worldwide Product Labeling</li><li>Directing and supervising the US Office of Promotion and Advertising Review</li><li>Directing and supervising the US Subsidiary regulatory operations</li><li>Directing and supervising the Drug Device/Combination Products Center of Excellence</li><li>Providing strategic and tactical direction and execution of cross product and GRACS cross functional projects and teams as assigned.</li></ul>Key Accountabilities:<ul><li>Directs activities of the General Medicine global regulatory therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for Cardiovascular, Diabetes, Respiratory, Immunology, Neuroscience and Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings overseeing the progress of those development programs.</li><li>Inspires a high level of performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance, and external collaboration and influence through industry affiliations and relationships with health authorities. Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable rapid and effective decision making through empowerment of individuals. Embodies leadership behaviors to interact and increase effectiveness by enabling clear, concise communication directly to senior management at our company.</li><li>Partners with members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms. Reviews and resolves issues that span diverse areas and manages situations that are viewed as precedent setting. Guides internal teams to implement rigorous, innovative, and science-based approaches to regulatory interactions and requirements. Uses enhanced business acumen, strategic understanding of the regulatory environment globally and thinks beyond functional and divisional lines to drive decisions and strategies that are innovative, impactful and in our company's best interest.</li><li>Partners with members of GRACS Leadership Team to help our company build solid and trustworthy relationships with FDA and global health authorities. Pro-actively influences and manages relations with FDA and global health authorities to build consensus and ensure our company's regulatory strategies are implemented.</li><li>Partners with members of GRACS Leadership Team to strengthen our collaboration with our company's Chief Patient Office, Global Human Health (Commercial), Center for Observational and Real-World Evidence (CORE) and our Manufacturing Division internally to create a single voice of commitment to regulatory strategies that accelerate and maintain access of product through market authorization, execute of post marketing commitments and meet compliance obligations.</li></ul>Education: <ul><li>M.D. or PhD with >20 years relevant experience preferably with >15 years in Regulatory or M.S. or B.S. with >25 years relevant experience a majority of which was in Regulatory.</li></ul>Required Experience and Skills:<ul><li>Global Regulatory experience required across various modality types.</li><li>M.D. or PhD with >20 years relevant experience preferably with >15 years in Regulatory or M.S. or B.S. with >25 years relevant experience a majority of which was in Regulatory.</li><li>Demonstrated scientific knowledge, analytical ability, and effective written and verbal communication skills. </li><li>Demonstrated organizational leadership and management skills.</li></ul>Job Specific Competencies & Skills:<ul><li>Demonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is distributed globally.</li><li>Proven leadership and management skills with cross-functional teams, as well as inspiration and motivation skills.</li><li>Ability to set strategic goals in line with the business.</li><li>Excellent interpersonal communications, organizational, and presentation skills.</li><li>Superior negotiation and influencing skills.</li><li>Demonstrated experience with budgeting and planning.</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $326,300.00 - $513,600.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/8/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:07/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R298455

VP/TA Head, General Medicine - Global Regulatory Affairs

Job Description Our Animal Health team offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. The Millsboro, DE Animal Health facility is located in Sussex County, DE, within the Salisbury, MD-DE Metropolitan Area. Millsboro is situated at the first point on the Indian River and is conveniently located 20 minutes from the beautiful Delaware beaches and 40 minutes from Ocean City, MD. Millsboro is rich in culture and is home to the Nanticoke Indian Tribe. Free concerts in the park, the outdoor farmer's markets, dining at the many restaurants, antique and vintage shopping and boating are just some of the many ways people enjoy life in this quaint river town. We are looking for talented individuals to join our Production teams using key technologies for cell culture, filling and packaging. Join us and experience our culture first-hand - one of strong ethics and integrity, diversified experiences, and a passion for improving animal health. Our company, consistently cited as a great place to work, discovers, develops, manufactures, and markets a wide range of vaccines and medicines to address unmet medical needs. We are hiring Technicians within multiple products and processes including but not limited to: Sterile Services, Viral Bulk Manufacturing, Blend/Fill, Packaging, and Warehousing. The hiring team will evaluate your skills to determine where you can make the greatest positive impact as a Technician. Whether you have a diploma, degree, or in between, we will likely have something that fits you. What you can expect: Starting on day one, we will provide you the necessary training the Technician will need to follow Good Manufacturing Practices and Standard Operating Procedures and adhere to all safety and company policies while performing advanced laboratory services in various manufacturing areas. Throughout your career, we will offer you continued development through training classes, workshops, meetings, etc., to improve job skills and product-related procedures. Some duties may include but are not limited to the following:<ul><li>Work with a variety of manufacturing equipment while completing processes throughout the manufacturing cycle</li><li>Assist with equipment setup and operation.</li><li>Performs manual and/or automated operations, general maintenance and support functions</li><li>Housekeeping in all work areas | Executes facility decontamination according to approved procedures</li><li>Assist with performing aseptic procedures including media preparation, antigen inoculation and harvest, tissue culture preparation and harvest, filling vaccines, etc.</li><li>Assist with performing non-aseptic procedures including handling of live poultry in the process of harvesting tissue and waste.</li><li>Filling, labeling, capping, packaging, and inspecting product.</li><li>Concurrent record keeping including charts, log books, and all pertinent documentation.</li><li>Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel</li><li>May be accountable for accumulation, labeling and management of hazardous wastes, as appropriate to their area, providing you are properly trained prior to assignment.</li><li>Demonstrates, at all times, safe work habits and maintains a safe work environment. Comprehends and complies with all safety and company policies and procedures.</li><li>Assist in weekly reports as assigned.</li><li>Attend training classes, workshops, meetings, etc., as required to improve job skills and product-related procedures.</li></ul>Required Education:<ul><li>High School diploma/GED</li></ul>Required Experience:<ul><li>Ability to operate manufacturing equipment with training </li><li>Strong attention to detail and documentation skills are required</li><li>General knowledge of reading, mathematics and computer skills are required.</li><li>Ability to communicate and work in cooperation with other employees in a manufacturing environment.</li><li>Successful completion of a Physical Abilities Test.</li></ul>Working conditions:<ul><li>This position may have varying hours based on the needs of the business</li><li>May require a rotating shift</li><li>Flexibility working overtime is a requirement in manufacturing</li><li>Travel is not a part of this position</li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/10/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/10/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297780

Operations Technician

Job Description Summary, Focus and Purpose The Stability Specialist will support site stability programs and be responsible for executing stability strategies and protocols for both pre-commercial and commercial stability studies. This role will facilitate stability study management, including sample receipt, sample handling, protocol creation, stability study monitoring, and all associated GMP documentation. The Stability Specialist will support cross functional teams, including our Company sites and third parties as well as domestic and international sites. The employee will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site initiatives and continuous improvement projects. Key Functions<ul><li>Manages stability studies for vaccine and pharmaceutical products, including but not limited to sample handling and receipt, sample labeling, managing sample chain of custody, protocol creation, study builds, and study closeouts</li><li>Collaborates with partner sites and labs to coordinate sample shipment and receipt</li><li>Reviews annual stability reviews for licensed products for accuracy</li><li>Addresses and provides timely responses to product or project inquiries</li><li>Maintains GMP documentation per our Company policies and procedures</li><li>Supports deviation management for events related to stability operations or testing of stability samples. Supports implementation of corrective actions.</li><li>Responds to early warning limit excursions.</li><li>Authors or revises local Standard Operating Procedures</li><li>Effectively utilizes applicable computer applications, including Laboratory Information Management System, Microsoft Word, Excel, and statistical software applications</li></ul>Required Education<ul><li>Bachelor's degree in chemistry, Biological Science, Pharmacy, or related Science or Engineering field</li></ul>Preferred Experience<ul><li>Prior experience in laboratory, technical services, manufacturing, regulatory and/or other Quality position</li><li>Experience with vaccines, biologics, and/or devices</li><li>Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/6/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/06/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297213

Quality Specialist - Stability

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! ACCOUNTABILITY Provide overall administrative support for Biologics Value Chain Management and North America Supply Chain Operations organizations. This will include direct support to AVP and Exec. Director leaders of the subject organizations, coordination of organizational and cross-functional governance meetings, opportunistic assistance of organizational team members, backup administrative support to the SVP head of Global Supply Chain Management, with opportunity to contribute to broader organizational goals through elective assignments. DUTIES Responsible for supporting Biologics Value Chain Management (led by AVP) and North America Supply Chain Operations (led by Executive Director). The individual selected must have the ability to prioritize and complete deliverables across multiple stakeholders; have strong verbal and written communication skills; ability to work both independently and collaboratively; be comfortable with multi-tasking on diverse responsibilities; be flexible, and able to work in a fast paced, deadline-driven environment. A high degree of professionalism and confidentiality is required due to the sensitive nature of work supported by the team. The ability to build and manage relationships in a cross-functional, matrix organization is necessary. A strong orientation toward data analytics with comfort working in business systems as well as Microsoft applications is required. Responsibilities include, but are not limited to:<ul><li> Partner across the Supply Chain, and cross functional organization to ensure that Biologics VCM and NA SCM Ops business goals are met. </li><li> Managing the calendar, including appointments, meetings, conferences, and travel arrangements for the organizational leaders and direct reports as needed. </li><li> Proactive collaboration with administrative assistants of other senior leaders to ensure optimal date selection when scheduling meetings. </li><li> Work as part of an integrated administrative team within Supply Chain Management, providing temporary support to other parts of the organization as needed. </li><li> Leveraging organizational systems to run reports; disaggregate and re-aggregate data; provide basic analysis/insights based on data. </li><li> Preparing, processing, and reconciling expense reports, purchase orders, and payment requests, as needed. </li><li> Manage distribution lists, team sites, electronic files, and other data in a systematic way for enduring use. </li><li> Maintaining appropriate filing system to provide prompt retrieval of all reports, correspondence, and other materials while maintaining compliance related to company retention schedules and legal holds. </li><li> Creating and distributing highly confidential correspondence and reports; monitoring and screening communications for action or delegation. </li><li> Responding effectively and in a timely manner to numerous stakeholders to answer questions and direct people to the right resource to resolve problems. </li><li> Adhere to all compliance and policy requirements of organization and the company. </li><li> Support other routine or ad hoc tasks and projects as assigned. </li></ul>In accordance with Policy 82 - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. QUALIFICATIONS Essential:<ul><li>At least 6 years of experience working in organization administration/project management.</li><li>Excellent organization, planning, communication and presentation skills.</li><li>Proven success working in a team environment with flexibility and adaptability to react to changing business needs with a can-do" approach.</li><li>Ability to appropriately handle and control sensitive business information.</li><li>Operate autonomously, anticipating and prioritizing work to be done and applying knowledge/skills to more complex problems.</li><li>Ability to manage multiple priorities and know when to escalate issues for resolution.</li><li>Efficiency in communicating complex information to staff at different levels.</li><li>Strong stakeholder management skills to manage both internal and external stakeholders that support the organization.</li><li>Solve complex problems; takes a new perspective on existing solutions.</li><li>Ability to challenge the status quo with a continuous improvement mindset.</li><li>Calendar Management and Appointment and Interview scheduling experience.</li></ul>Preferred:<ul><li>Business Administration and/or project management diploma desirable</li><li>Advanced skills in MS Word, Excel, PowerPoint, Sharepoint.</li><li>Proven record of accomplishments in a regulated industry.</li><li>Strong analytical/statistical problem-solving skills, coaching and facilitation skills.</li><li>Proficient in Project Planning and Execution and experience of coordinating programs across organizations,</li></ul>Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. MSJR VETJOBS If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296526

Senior Administrative Assistant - Biologics VCM and North America Supply Operations

Job Description P2 : Process Support Lab Specialist Job Description: The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company's Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility. The Process Support Lab Associate Specialist will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for lab-scale vaccine process development execution, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs. The well-qualified candidate must have analytical, problem-solving, and communication skills. Furthermore, the candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments and/or the vaccine production schedule. Key responsibilities may include but are not limited to:<ul><li>Provide technical hands-on support in execution of lab-scale experiments in one of the following areas: (1) downstream processing including buffer preparation, benchtop homogenization, resin chromatography purification, and TFF/NFF operations, or (2) bio-analytical assays for in-process and post-processing samples (ie, SDS-PAGE, BCA Total Protein, UV/Vis, DLS, UPLC-SEC, SoloVPE, microbial growth).</li><li>Serve as a study lead with responsibility for scheduling operations, leading experimental design planning, ordering materials, and overseeing experiment execution to ensure all activities are completed successfully. </li><li>Provide technical leadership and team support in hands-on execution of lab-scale experiments and support assay qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.</li><li>Lead in design, execution and data analysis for laboratory experiments. Scope of work may include supporting process characterization and commercial technology transfer associated with the development and implementation of the new vaccine processes, and as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.</li><li>Troubleshoot equipment and assays as needed.</li><li>Ability to support non-routine 2nd and 3rd shift work if needed based on experimental designs or customer needs.</li><li>Author and present experimental design proposals, technical reports and documents to peers and stakeholders.</li><li>Compile process data and employ statistical tools for experimental analysis and process monitoring.</li><li>Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine processes.</li></ul>Education Minimum Requirement:<ul><li>Bachelor's Degree or higher in Engineering or Sciences, with relevant academic experience with at least two (2) years of relevant experience.</li></ul>Required Experience and Skills:<ul><li>Strong leadership, interpersonal and communication skills (written and oral).</li><li>Experience in vaccine or biologics processing, including either lab- or manufacturing- scale support in downstream or analytics. </li></ul>Preferred Experience and Skills:<ul><li>Hands-on experience in large molecule purification (chromatography, filtration) or bio-analytical assays.</li><li>Ability to drive studies and experiments in the context of a long-term commercialization plan.</li><li>Ability to provide scientific mentorship and guidance to technical colleagues.</li><li>Take lead in solving technical problems and equipment issues.</li><li>Proficient using statistical tools (JMP or Minitab) for experimental design, data analysis and modeling.</li><li>Experience with Design of Experiments (DOE).</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R298091

Specialist - Vaccine Process Support Laboratory

Job Description Associate Director - Digital Forensics Position Summary: We are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director will be responsible for leading and managing all aspects of the lab, including supervising a team of digital forensics analysts, ensuring the lab operates efficiently, and driving innovation and best practices in digital forensics investigations. Key Responsibilities: Laboratory Supervision and Management: Oversee the day-to-day operations of the digital forensics lab, ensuring all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical guidance to a team of digital forensics analysts, assign and prioritize workload, and ensure the lab maintains a high standard of quality and accuracy. Digital Forensics Investigations: Conduct and oversee complex digital forensic investigations, including the extraction, preservation, and analysis of digital evidence from various devices and platforms. Collaborate with internal teams and external stakeholders to support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance: Develop and implement protocols and procedures to ensure the integrity and quality of digital forensic analyses and reports. Research and Innovation: Stay updated on the latest trends, methods, tools, and technologies in the field of digital forensics. Drive innovation and seek opportunities to enhance the capabilities of the lab through research, testing, and development of new forensic techniques, tools, and methodologies. Team Development and Training: Provide guidance, mentorship, and professional development opportunities to the digital forensics team. Identify training needs, coordinate training sessions, and ensure team members remain current with evolving forensic techniques and methodologies. Collaboration and Partnerships: Collaborate with the Global Security Group, legal professionals, and other relevant stakeholders to support investigations, assist in legal proceedings, and establish partnerships for information sharing and research collaboration. Budgeting and Resource Allocation: Collaborate with senior management to develop and manage the lab's budget. Optimize resource allocation to ensure the lab has the necessary tools, equipment, software, and systems to effectively carry out digital forensic investigations. Requirements:<ul><li>Bachelor's degree</li><li>Proven experience 6 years in digital forensics investigations, with a focus on computer and mobile device forensics.</li><li>Deep knowledge and understanding of digital forensic principles, techniques, and methodologies.</li><li>Strong leadership and managerial skills, with the ability to effectively lead and motivate a team.</li><li>Proficiency in forensic tools such as Magnet, Crowdstrike, Cellebrite, and open-source software.</li><li>Excellent analytical and problem-solving skills.</li><li>Strong communication and interpersonal skills, with the ability to collaborate effectively across teams and stakeholders.</li><li>Demonstrated report writing skills and ability to communicate technical topics to non-technical audiences.</li><li>Demonstrated ability to stay updated on the latest developments in digital forensics through continuous learning and professional development.</li></ul>Preferred Qualifications:<ul><li>Bachelor's degree in Digital Forensics, Computer Science, or a related field preferred.</li><li>Proven experience 6 years managing digital forensics investigations in a supervisory role.</li><li>Demonstrated understanding of digital forensic principles, techniques, and methodologies by authoring published research or technical papers.</li><li>Forensic certifications to include GIAC GCFE, GNFA, GCIA, GIME, or GASF. CISSP is also preferred.</li><li>Familiarity with industry standards and regulations, such as ISO 17025 and ANSI/NIST.</li><li>Strong communication and interpersonal skills, with the ability to collaborate, as demonstrated in presentations to the forensics or information security communities at industry conferences.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297549

Associate Director, Digital Forensics (Hybrid, Rahway NJ)

Job Description The Specialist operates under the guidance of a Director or an Associate Director in the Global Engineering Solutions team supporting Technology Process and MPS Engineering, Project Delivery, or Project Estimating and Controls for a Line of Business (e.g. Large Molecule, Small Molecule or Animal Health). The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. The Specialist would be responsible for, but not limited to: <ul><li>Planning, design, and implementation of capital projects including scope generation</li><li>Conceptual estimating</li><li>Process & facility design,</li><li>Capacity Assessments</li><li>Equipment selection</li><li>Vendor interaction</li><li>Factory acceptance testing</li><li>Technology transfer</li><li>Construction support and/or management</li><li>Project controls - cost and/or schedule</li><li>Equipment qualification</li><li>Facility start-up</li><li>Process demonstration</li></ul>Candidates possessing capital management experience or expertise are preferred for this role. Ideal candidate will possess superior communication and technical skills, a team player with the ability to work independently. We are seeking candidates with outstanding records of achievement and demonstrated leadership abilities, candidates who are analytical and inquisitive about the interrelationships of various components, and perceptive, quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading pharmaceutical, biologic and vaccine products. The candidate should have a strong understanding of the line of business, understand MPS principles and how to apply them to design and delivery, implement standard work and be able to lead technical areas and small capital projects from an end to end perspective. Flexibility with travel up to 50% and work location is also required. Qualifications - External Education:<ul><li>Bachelors Degree or higher in Mechanical, Chemical, or Computer/Electric Engineering or Applicable Science</li></ul> Required: <ul><li>Minimum of two years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree).</li><li>Minimum of two years project leadership and/or management</li><li>Written and verbal communication, leadership and teamwork skills. </li><li>Experience with engineering design, equipment operation, vendor interface, risk assessment and process safety</li><li>Ability to travel, both domestic and international</li></ul> Preferred:<ul><li>Estimating and/or Project Controls experience or expertise</li><li>Capital Management Process Experience</li><li>Experience with equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification</li><li>Construction Management Experience</li><li>MPS Capacity Assessment and Improvement Experience</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/7/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/07/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R290267

Spclst, Engineering, GES Merck Production Systems (MPS) COE

Job Description Position Description:Specialist, Manufacturing Automation (Hybrid) g, quality and engineering groups. Supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automatio The Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC. As an Automation Engineer, you are responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with manufacturin n technologies and make a positive impact. Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the Automation team. Also provides technical coverage on automated systems. Primary Activities include, but are not limited to:<ul><li> Understands and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations. Review and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety. </li><li> Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions. </li><li> Evaluates automated and information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. </li><li> Assists in the Automation Lead in the training, development, motivation, and assignments for employees and contractors. </li><li> Coordinates projects with staff group for timely implementation. </li><li> Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. </li><li> Participates in audits and training programs in the area of responsibility. </li><li> Project coordination leadership and implementation of troubleshooting activities and change control. </li><li> Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems. </li><li> On-floor support of manufacturing activities. </li><li> Identify and implement process/equipment improvements and manufacturing efficiencies. </li><li> Serves as liaison with corporate and divisional automation and IT groups. </li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>High School Diploma and 3+ years of process automation experience OR</li><li> B.S., B.A., or greater preferably in Engineering, Science, or Information Technology and 1+ years of experience in process automation or equivalent area. </li></ul>Required Experience and Skills: <ul><li> Experience programming Emerson DeltaV or PLCs (ladder logic, HMIs, or SCADA) required. </li><li> Computer validation and systems life-cycle development methodology experience required. </li></ul>Preferred Experience and Skills:<ul><li> Experience working with Information Technology teams. </li><li> Experience working with AVEVA/OSIsoft PI System. </li><li> Experience working with InfoBatch and/or AgileDoc Workflow. </li><li> Experience with regulatory audits and working knowledge of data integrity principles. </li><li> Understanding of Lean Manufacturing /Six Sigma methodology. </li><li> Strong leadership, interpersonal and communication skills. </li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296084

Specialist, Manufacturing Automation (Hybrid)

Job Description The West Point, PA campus is our Company's largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future. The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up of a new vaccine filling & lyophilization facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure. The Specialist, Operations will be an energetic team member with strong collaboration skills responsible for partnering with multiple functions to execute facility design, construction, startup and operational readiness. Upon completion of the facility design & construction this is targeted for promotion to a Manager role directing the operators and the daily execution in the facility. Primary Responsibilities: Reporting to the Associate Director of Operations or Operations Manager, the Operations Specialist primary responsibility will be to help facilitate day to day production and support of operations. He/she will partner with area Manager to assist with ship floor management This position will require off-shift or weekend coverage based on business unit needs and specific assignments. The Operations Specialist has the opportunity to develop into a manager with a rapidly growing pharmaceutical manufacturer<ul><li>Assists Operations manager in execution of duties</li><li>Delivers operational improvements on key business projects, including updating weekly metrics and deliverables</li><li>Promote a culture of continuous improvement and challenging the status quo</li><li>Complete documentation of deviation events</li><li>Complete production batch record review (post- Production)</li><li>Coach and provide oversight on shop floor to identity potential issues before they arise and prevent deviations</li><li>Ownership of the Leader standardized work process which prioritizes resolution of issues from the shop floor and drives resolution through 8-step problem Solving and other Lean tools.</li><li>Collaborate with peers on global teams to ensure a positive learning organization, alignment of strategy and sharing best practices</li><li>Mentor others on effective communication and active listening techniques to fully understand needs and expectations</li><li>Assist operations team and shop floor to with defining the requirements of the electronic batch record and successful execution</li></ul>Minimum Required Education, Experience and Skills:<ul><li>Bachelor's degree or higher, preferably in Science, Engineering, Business Administration, or another technical field </li></ul> OR <ul><li>High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service</li></ul> AND <ul><li>Willing and able to work off-shifts and weekends as needed</li></ul>Preferred Experience and Skills:<ul><li>Demonstrated record of successfully working in team environments and influencing people with a broad range of skills and experience. </li><li>Performance mindset to drive and influence behaviors on the floor</li><li>Self-motivation, ambition, resilience, and confidence in taking risk</li><li>Lean, Six Sigma problem solving skills coupled with a continuous improvement mindset</li><li>Ability to prioritize, focus on and obtain business results</li><li>Excellent communication and organizational skills</li><li>Technical writing experience related to procedures and investigations</li><li>SAP, MES and DeltaV experience is an advantage</li></ul>Shifts: 1st Shift Tue-Sat NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS MSJR Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/6/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/06/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R298102

Specialist, Operations (1st Shift)

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Under the supervision of a Senior Specialist or Associate Director, the Associate Specialist is responsible to provide day-to-day equipment and facility engineering support for assigned area including vaccine bulk manufacturing, and/or associated facility/utilities mechanical support. Assigned tasks include support and monitoring of equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations. Actively ensures compliance to current Good Manufacturing Practices (GMP), Safety, and Environmental regulations while achieving operating cost goals. Position Responsibilities<ul><li>Reports to and receives supervision from a Senior Specialist or Associate Director. On routine process operations, is guided by standard operating procedures</li><li>Provides shop floor day-to-day equipment/instrumentation/robotic and utilities engineering support to manufacturing operations</li><li>Ensures adequate spare parts inventory, optimizes and coordinates scheduling of preventative, predictive and corrective maintenance to improve equipment reliability</li><li>Interacts with hourly, salaried and contract employees in routine matters, troubleshooting equipment and automation systems</li><li>Provides supervisory coverage when required. Assists in the training of hourly employees. Promotes open communications and team work</li><li>Maintains a high level of technical knowledge and may coordinate safety, current Good Manufacturing Practices, and environmental compliance programs</li><li>Actively supports productivity improvement program and resolution of deviation events. Participates in root cause investigations, evaluates, develops and improves business processes and develops technical rationale for system improvements</li><li>Develops Qualification, Standard Operating Procedures (SOP) and Preventative Maintenance documentation and provides reports, data and information to support ongoing operations</li><li>Executes projects from concept to qualification, which may involve facilities, utilities, equipment, automation, or process related upgrades based on project requirements and site procedures</li><li>Summarizes project progress, delays, or improvement opportunities. Frequently communicates with immediate supervisor about status of projects or assignments</li><li>Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues</li><li>Supports regulatory agency inspections</li></ul>Education Minimum <ul><li>B.S. Engineering, Science, or four (4) year Engineering Technology Degree</li></ul>Required Experience and Skills<ul><li>Minimum one (1) year of cGMP, technical/mechanical services experience</li><li>Good interpersonal skills including flexibility and ability to work in a team environment</li><li>Good analytical abilities, organizational skills, written and verbal communication skills</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297441

Associate Specialist, Engineering, Maintenance & Utilities

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Under the supervision of a Senior Specialist or Associate Director, the Associate Specialist is responsible to provide day-to-day equipment and facility engineering support for assigned area including vaccine bulk manufacturing, and/or associated facility/utilities mechanical support. Assigned tasks include support and monitoring of equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations. Actively ensures compliance to current Good Manufacturing Practices (GMP), Safety, and Environmental regulations while achieving operating cost goals. Position Responsibilities<ul><li>Reports to and receives supervision from a Senior Specialist or Associate Director. On routine process operations, is guided by standard operating procedures</li><li>Provides shop floor day-to-day equipment/instrumentation/robotic and utilities engineering support to manufacturing operations</li><li>Ensures adequate spare parts inventory, optimizes and coordinates scheduling of preventative, predictive and corrective maintenance to improve equipment reliability</li><li>Interacts with hourly, salaried and contract employees in routine matters, troubleshooting equipment and automation systems</li><li>Provides supervisory coverage when required. Assists in the training of hourly employees. Promotes open communications and team work</li><li>Maintains a high level of technical knowledge and may coordinate safety, current Good Manufacturing Practices, and environmental compliance programs</li><li>Actively supports productivity improvement program and resolution of deviation events. Participates in root cause investigations, evaluates, develops and improves business processes and develops technical rationale for system improvements</li><li>Develops Qualification, Standard Operating Procedures (SOP) and Preventative Maintenance documentation and provides reports, data and information to support ongoing operations</li><li>Executes projects from concept to qualification, which may involve facilities, utilities, equipment, automation, or process related upgrades based on project requirements and site procedures</li><li>Summarizes project progress, delays, or improvement opportunities. Frequently communicates with immediate supervisor about status of projects or assignments</li><li>Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues</li><li>Supports regulatory agency inspections</li></ul>Education Minimum <ul><li>B.S. Engineering, Science, or four (4) year Engineering Technology Degree</li></ul>Required Experience and Skills<ul><li>Minimum one (1) year of cGMP, technical/mechanical services experience</li><li>Good interpersonal skills including flexibility and ability to work in a team environment</li><li>Good analytical abilities, organizational skills, written and verbal communication skills</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297442

Offshift Associate Specialist, Engineering, Maintenance & Utilities

Job Description P1 : Process Support Lab Associate Specialist Job Description: The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company's Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility. The Process Support Lab Associate Specialist will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for lab-scale vaccine process development execution, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs. The well-qualified candidate must have analytical, problem-solving, and communication skills. Furthermore, the candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments and/or the vaccine production schedule. Key responsibilities may include but are not limited to:<ul><li>Provide technical hands-on support in execution of lab-scale experiments in one of the following areas: (1) downstream processing including buffer preparation, benchtop homogenization, resin chromatography purification, and TFF/NFF operations, or (2) bio-analytical assays for in-process and post-processing samples (ie, SDS-PAGE, BCA Total Protein, UV/Vis, DLS, UPLC-SEC, SoloVPE, microbial growth)</li><li>Assist in design, execution and data analysis for laboratory experiments. Scope of work may include supporting process characterization and commercial technology transfer associated with the development and implementation of the new vaccine processes, and as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.</li><li>Lead troubleshooting of relevant equipment and assays as needed.</li><li>Ability to support non-routine 2nd and 3rd shift work if needed based on experimental designs or customer needs.</li><li>Author and present experimental design proposals, technical reports and documents to peers and stakeholders.</li><li>Compile process and analytical data, and employ statistical tools for experimental analysis and process monitoring.</li><li>Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine processes.</li></ul>Education Minimum Requirement:<ul><li>Bachelor's Degree or higher in Engineering or Sciences, with relevant academic experience.</li></ul>Required Experience and Skills:<ul><li>Strong leadership, interpersonal and communication skills (written and oral).</li></ul>Preferred Experience and Skills:<ul><li>Hands-on experience in large molecule purification (chromatography, filtration) or bio-analytical assays.</li><li>Experience designing experiments and authoring technical documentation.</li><li>Solves technical problems independently</li><li>Strong attention to detail</li><li>Ability to foster collaborative work environment</li><li>Demonstrated systematic problem solving skills</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS #EBRG Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R298093

Associate Specialist - Vaccine Process Support Laboratory

Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. GENERAL SUMMARY The Director of Operations (Integrated Process Team (IPT) Lead) is an exciting opportunity to lead a new manufacturing area at the Durham, North Carolina Site. This role will lead the operations team to deliver the facility startup, process validation, regulatory submission, PAI, and ultimately the commercial manufacture of the product's Drug Substance. GENERAL PROFILE <ul><li>Provides leadership and direction to ensure that short and long term IPT objectives are achieved while reliably supplying quality product at a competitive cost and consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment, and safety.</li><li>Develops and cultivates a Production System (MPS) and continuous improvement culture while achieving MPS Targets and business outcomes for the IPT.</li><li>Creates and sustains a highly engaged workforce through utilization of Enterprise Leadership Skills and Inclusion.</li><li> Provides guidance and makes decisions to ensure the safety of the employees is always maintained. </li><li>Development and management of the IPT operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost.</li><li>Resolves complex technical, operational, and financial problems.</li><li>Prioritizes based on departmental budget and profit plan to address resource and operational challenges.</li><li>Leads and directs the operations organization of approximately 100 through managers, individual contributors, and technicians.</li><li>Develops business plans, including financial, production and/or organizational priorities.</li><li>Prioritizes based on departmental budget and profit plan to address resource and operational challenges.</li><li>Leverages relationships with key clients and/or customers to support business needs.</li></ul> PEOPLE MANAGEMENT <ul><li>Leads Production team for the new Durham, NC HPV Bulk manufacturing organization, including associate directors, coaches, technicians and engineers (100 people)</li><li> Provides coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect IPT reports. </li></ul> FINANCIAL MANAGEMENT <ul><li> Responsible for development and management of the IPT operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost; Ensure members of the IPT have high business acumen and understand how they may impact business finances. </li></ul> QUALIFICATIONS Essential:<ul><li>Bachelor Degree in Engineering, Science or related field</li><li>Minimum 10 years of experience in Manufacturing, Technical Operations, Management Engineering, Science & Technology, Site Engineering Services with extensive supervisory responsibility with exempt and hourly personnel</li><li>Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/Iean processing</li></ul>Preferred:<ul><li>Demonstrated ability to create an engaged workforce</li><li>Demonstrated experience of interacting with regulatory agencies via on-site inspections</li><li>Demonstrated successes with Talent Management, reorganization and strategic initiative</li></ul>Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): None Job Posting End Date: 06/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296582

Manufacturing Director (Drug Substance)

Job Description Our company is looking for a Data Engineering & Visualization Specialist who will be capable of managing and enhancing our data functions broadly. Key Responsibilities: Data Visualization: Building dashboards and reports, managing data relationships from different sources, designing clear and informative reports. Data Engineering: Building and managing ETL pipelines, managing automated data flows across Microsoft services, designing data processing scripts using Python. Data Governance: Designing processes for data intake, management, governance, and workflow, implementing workflow/process improvements on project management systems. Software Engineering: Experience with version control and related tools, maintaining custom Python libraries/packages, documenting code and repository maintenance. Required Qualifications:<ul><li>Experience in data visualization, data engineering, data governance, and software engineering.</li><li>Familiarity with Agile Scrum methodology.</li><li>Relevant experience in building dashboards and reports on complex data models.</li><li>Excellent communication and presentation skills.</li><li>Experience in ETL pipelines and automated data flows.</li><li>Ability to design data processing scripts using Python.</li><li>Experience with project management tools like Jira and Confluence.</li><li>3 years experience</li></ul>Technical Skills:<ul><li>Python: asyncio, httpx, ujson, concurrent.futures, pandas, numpy, datetime, re.</li><li>Command line interface (unix, bash, etc.)</li><li>PowerBI.</li><li>OpenSearch/ElasticSearch.</li><li>SQL.</li><li>R.</li><li>HTML, CSS, JS.</li><li>TIBCO Spotfire.</li></ul>Preferred Qualifications:<ul><li>Experience with cloud-based ETL pipelines, data warehousing, and data architecture.</li><li>Knowledge of best practices in UI/UX and accessible design.</li><li>Familiarity with SQL databases, OpenSearch, Elasticsearch, and/or Kibana.</li><li>Web development skills (HTML, CSS, and JS).</li><li>Experience with Spotfire for data visualization.</li><li>Ability to create descriptive and predictive models.</li></ul>Education Minimum Requirement:<ul><li>Minimum of a high school diploma</li></ul>At our Company, we value diversity and believe that good performance management is critical to our ongoing success. If you are ready to take up these exciting tasks with us, please apply. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296426

Data Engineer & Visualization Specialist (Hybrid)

Job Description The Engineering Maintenance and Site Service department within the site is seeking a highly motivated individual for a Calibration Technician position. This individual will partner with Maintenance management, and work with Manufacturing Operations, Quality, and Global Engineering Services as a member of the EMSS. The EMSS team provides technical, calibration, maintenance, and engineering support for the manufacturing in Durham, NC. The Calibration Technician is recognized as a knowledgeable resource in maintenance, calibration, and technical areas and consulted in decision making. The individual in this role will be responsible for maintaining equipment data, performing Preventative Maintenance (PM) and unplanned repair activities, calibration activities and PM/Calibration documentation, schedule adherence, working with customers, analyzes equipment performance, and assist in writing maintenance/calibration work instructions. The Calibration Technician will use computerized systems such as SAP for PM data entry and report generation. Will also be using Procal for any calibration entry. The calibration Technician will also use systems related to EMSS such as MES, Delta V, and other software systems. Position Responsibilities:<ul><li>Communicate effectively to Operations and scheduling personnel. Able to prioritize scheduled work. Self-motivated, applies knowledge, and skills to other areas within the department; provides technical guidance and training to others. Anticipates and solves complex production/operational problems.</li><li>Effectively coordinates work across upstream and downstream team members. Guide's others in seeking out ideas and information to improve customer service. Demonstrates ability to meet customer expectations in term of quality/quantity and on-time delivery as appropriate.</li><li>Oversee and maintain schedule adherence and unplanned maintenance, and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.</li><li>Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.</li><li>Troubleshoots equipment and performs necessary repairs. Utilizes various instruments and diagnostic tools (such as meters, HART communicators and Foundation Fieldbus protocol devices, pressure, electrical, and leak detectors) to facilitate analysis and repair of equipment and control systems.</li><li>Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures.</li><li>Uses the SAP work order system to review work requests, identify required stock and non-stock materials, ensure availability, writes incursions for upcoming work, performs work orders to completion, and maintain equipment histories.</li><li>Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment.</li><li>Obtains bids, reviews contract, supervises, and follows-up on contract work including the auditing of time and material reports.</li><li>Assists in maintaining spare parts inventory storeroom with the potential of occasional lifting of up to 30 pounds.</li><li>Perform other tasks as requested by site management to meet the requirements and goals.</li><li>Perform out of tolerance reports, which may include doing reverse traceability. Calibration Drift analysis and executing changes to improve calibration program.</li><li>"Self-starter" attitude and ability to learn and understand new equipment or instrumentation.</li><li>Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration.</li><li>Review's vendor calibration certificates.</li><li>Maintain working calibration standards.</li><li>Perform ProCal Entries such as calibration or change controls as needed.</li></ul>Education Requirements:<ul><li>High School Diploma or equivalent is required for this position.</li></ul>Required Experience:<ul><li>Two (2)+ years GMP manufacturing/processing experience.</li><li>Must be willing to work 12-hour day shift on a rotating 2-2-3 schedule. Note that this schedule does include working alternating weekends and holidays.</li><li>Must be able to successfully pass and maintain aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots. </li><li>Must be willing to be qualified in aseptic operations and perform operator roles as needed. </li><li>Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator. </li><li>Computer literacy (internet browsers, e-mail, spreadsheets, word processing). </li></ul>Preferred Experience:<ul><li>Associate degree in electrical, electronics, instrumentation or any other related degree.</li><li>ASQ CCT Certification and or ISA CCST Certification (Any Level)</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #VETJOBS #EBRG MSJR Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296646

Tech, Calibration/Instrumentation (Days)

Job Description The Engineering Maintenance and Site Service department within the site is seeking a highly motivated individual for a Senior Calibration Technician position. This individual will partner with Maintenance management, and work with Manufacturing Operations, Quality, and Global Engineering Services as a member of the EMSS. The EMSS team provides technical, calibration, maintenance, and engineering support for the manufacturing in Durham, NC. The Senior Calibration Technician is recognized as a knowledgeable resource in maintenance, calibration, and technical areas and consulted in decision making. The individual in this role will be responsible for maintaining equipment data, performing Preventative Maintenance (PM) and unplanned repair activities, calibration activities and PM/Calibration documentation, schedule adherence, working with customers, analyzes equipment performance, and assist in writing maintenance/calibration work instructions. The Senior Calibration Technician will use computerized systems such as SAP for PM data entry and report generation. Will also be using Procal for any calibration entry. Responsibilities: <ul><li>Communicate effectively to Operations and scheduling personnel.</li><li>Able to prioritize scheduled work. Self-motivated, applies knowledge, and skills to other areas within the department; provides technical guidance and training to others.</li><li>Anticipates and solves complex production/operational problems.</li><li>Effectively coordinates work across upstream and downstream team members.</li><li>Guide's others in seeking out ideas and information to improve customer service. Demonstrates ability to meet customer expectations in term of quality/quantity and on-time delivery as appropriate.</li><li>Oversee and maintain schedule adherence and unplanned maintenance, and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.</li><li>Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.</li><li>Troubleshoots equipment and performs necessary repairs.</li><li>Utilizes various instruments and diagnostic tools (such as meters, HART communicators and Foundation Fieldbus protocol devices, pressure, electrical, and leak detectors) to facilitate analysis and repair of equipment and control systems.</li><li>Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures. </li><li>Uses the SAP work order system to review work requests, identify required stock and non-stock materials, ensure availability, writes incursions for upcoming work, performs work orders to completion, and maintain equipment histories.</li><li>Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment.</li><li>Obtains bids, reviews contract, supervises, and follows-up on contract work including the auditing of time and material reports.</li><li>Assists in maintaining spare parts inventory storeroom with the potential of occasional lifting of up to 30 pounds.</li><li>Perform other tasks as requested by site management to meet the requirements and goals of the Site Integrated Process Team.</li><li>Perform out of tolerance reports, which may include doing reverse traceability. Calibration Drift analysis and executing changes to improve calibration program.</li><li>"Self-starter" attitude and ability to learn and understand new equipment or instrumentation.</li><li>Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration orders.</li><li>Review's vendor calibration certificates.</li><li>Maintain secondary and or working calibration standards.</li></ul>Education Requirements:<ul><li>High School Diploma or equivalent is required for this position.</li></ul>Required Experience:<ul><li>Two (2) years of experience GMP manufacturing/processing experience.</li><li>Must be willing to work 12-hour day shift on a rotating 2-2-3 schedule. Note that this schedule does include working alternating weekends and holidays </li><li>Must be able to successfully pass and maintain aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots. </li><li>Must be willing to be qualified in aseptic operations and perform operator roles as needed. </li><li>Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator. </li><li>Computer literacy (internet browsers, e-mail, spreadsheets, word processing). </li></ul>Preferred Experience:<ul><li>Associate degree in electrical, electronic instrumentation</li><li>ASQ CCT Certification and or ISA CCST Certification (Any Level)</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EBRG #VETJOBS MSJR Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 3rd - Night Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296645

Senior Tech, Calibration/Instrumentation (Days)

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Summary, Focus and Purpose: Under the supervision of a Senior Specialist or Associate Director, the Engineering EM&U Specialist is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU) and provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units. You will support and monitor equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations and actively ensure GMP quality, safety, environmental, and operating cost goals are achieved. On occasion, may provide supervisory coverage to ensure supply of a quality product. Key Functions:<ul><li>Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations</li><li>Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, conducts root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs | Develops maintenance and repair strategy for bi-annual shutdowns</li><li>Assists/Leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction</li><li>Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing</li><li>Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability</li><li>Supports maintenance scheduling and planning processes in area of responsibility</li><li>Supports positive safety culture and participates in HAZOP reviews and Safety inspections | Promotes open communications, inclusion and teamwork</li><li>Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors</li><li>Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan</li><li>Explains and enforces all GMPs, safety, and environmental regulations</li><li>Assist in audits, regulatory inspections and training in the area of responsibility</li></ul>Education:<ul><li>Bachelor of Science or Engineering degree or four year Engineering Technology degree</li></ul>Required Experience and Skills:<ul><li>Three years manufacturing experience or technical support group or equivalent</li><li>Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills</li><li>Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI)</li></ul>Preferred Experience and Skills:<ul><li>Experience with WFI/PS, HVAC/R, Compressed Air or other Utility systems </li><li>Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297437

Engineering EM&U Specialist - Offshift

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Summary, Focus and Purpose Under the supervision of a Senior Specialist or Associate Director, the Engineering EM&U Specialist is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU) and provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units. You will support and monitor equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations and actively ensure GMP quality, safety, environmental, and operating cost goals are achieved. On occasion, may provide supervisory coverage to ensure supply of a quality product. Key Functions<ul><li>Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations</li><li>Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, conducts root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs | Develops maintenance and repair strategy for bi-annual shutdowns</li><li>Assists/Leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction</li><li>Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing</li><li>Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability</li><li>Supports maintenance scheduling and planning processes in area of responsibility</li><li>Supports positive safety culture and participates in HAZOP reviews and Safety inspections | Promotes open communications, inclusion and teamwork</li><li>Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors</li><li>Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan</li><li>Explains and enforces all GMPs, safety, and environmental regulations</li><li>Assist in audits, regulatory inspections and training in the area of responsibility</li></ul>Education<ul><li>Bachelor of Science or Engineering degree or four year Engineering Technology degree</li></ul>Required Experience and Skills<ul><li>Three years manufacturing experience or technical support group or equivalent</li><li>Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills</li><li>Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI)</li></ul>Preferred Experience and Skills<ul><li>Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/17/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/17/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R297438

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