Senior Specialist, Engineering - Supplier Change Control

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

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.

The Senior Specialist,Supplier Change ControlEngineering position within the Shared Services End to End is responsible for providing and occasionally leading technical support to the Shared Services Incoming Materials area while actively supporting, participating in, and embracing an empowered team culture. While working primarily as an individual contributor, the individual may act as a team or project lead and lead the work of others as required.

Primary Responsibilities:
  • Contributes to the performance and results of a department. Provides technical guidance. Anticipates and interprets client and/or customer needs to identify and implement solutions.
  • Manages change controls from notification through closure meeting timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.
  • Serves as a liaison between site and Global Technical Operations and site Lab Services.
  • Provides data analysis of the change controls including the creation/ updating of trending reports.
  • Coaches, manages, and develops a team of engineers through an indirect reporting relationship.
  • Leads and/or executes process improvement projects and complex changes.
  • Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve issues.
  • Develops and assures consistent application of standardized work, engineering, and process tools.
  • Provides technical support to manufacturing for complex problems and issues.
  • Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
  • Authors and updates technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, change control, and validation.
  • Develops and assures consistent application of standardized work, engineering, and process tools.
  • Leads and/or works as a team member on vendor change controls, process improvement, and/or projects.
  • May serve as a technical reviewer/approver for vendor change controls, SOPs, and process changes.
  • Participates in regulatory inspection activities for the facility.
  • Provide leadership and manage efforts to supports supply chain duality.
  • Coach and mentor a group of scientist and engineers.


Education Minimum Requirements:
  • Required: Bachelors Degree in Engineering or Sciences
  • Preferred: Advanced degree (M.S.) in Engineering or Sciences


Required Experience and Skills:
  • Five (5) years post bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 3 years; Ph.D. degree plus 1 years).
  • Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role. Minimum 2 years experience in performing Change Controls (Authoring or Quality Approval).
  • Highly developed communication, leadership, and teamwork skills.
  • Ability to manage projects to schedule and budget.


Preferred Experience and Skills:
  • Regulatory inspection presentation experience with external regulatory authority representatives.
  • Six Sigma - Black or Green Belt certification.


Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R144266