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Description
Engineer-MAN001407
Description
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
As part of the Biotechnology Manufacturing / Viral Vaccine Manufacturing East (BTM/VVME) Technology Operations organization, the Engineer will provide support and be responsible for ensuring that cleaning and sterilization processes, as well as controlled temperature unit (CTU) qualification and process performance qualification, taking place in the BTM/VVME focus factories remain in a validated and/or qualified state. This colleague contributes to the completion of milestones associated with specific validation assignments. This role ensures product quality through robust validation testing and process monitoring. The colleague is expected to occasionally support off-shift and weekend work, as necessary, in alignment with the priorities of the BTM/VVME focus factories. The core responsibilities include developing and authoring validation protocols, executing developmental, investigational or validation studies, resolving technical issues encountered during study execution, and preparing validation final reports while adhering to the regulatory validation requirements, company standard operating procedures (SOPs), quality manual (QMS) procedures, and industry best practices.
In this role you will be:
* Focusing on design, execution, and closeout of validation studies.
* The basic function of this position is to design and implement varied technical projects requiring knowledge of engineering and/ or the biological/ physical sciences.
* The incumbent is expected to collect and interpret information and conceive, develop, and implement solutions to projects of a more general scope.
* Routine guidance and direction is employed by the manager to review soundness of technical judgment and the status/schedule of the effort.
* Writing / revising validation protocols and reports for continuing validations, initial validations, verification studies, developmental studies, investigational studies, for cleaning and steam sterilization processes in the BTM/VVME focus factories.
* Participating and assisting in:
* Generating and maintaining validation records in accordance with department procedures to ensure compliance with current standards.
* Preparing samples.
* Scheduling and coordination of validation activities with affected departments to ensure equipment is available and analytical laboratories ready to meet the validation schedule.
* Field execution of validation studies, any or all of the following types of validation studies: cleaning, steam sterilization, steam sanitization, process, CTU qualification.
* Investigative assistance and resolution of deviations.
* Preparation of validation equipment, such as calibration of thermocouples for temperature mapping studies, etc.
* Using validation test and measurement equipment in the execution of validation studies.
* Calculating and interpretation of analytical data generated in support of validation studies.
* Auditing, second person technical review functions as defined in study protocols.
* Tracking validation commitments;
* Delivering right-first-time (RFT) metrics: preparation of accurate validation documents, on time schedule adherence for field studies, error free execution of validation protocols and generation of final reports and on-time closure of completed studies.
* Researching historical documents required to prepare validation assessments.
* Ensuring timely issue escalation at the right level of decision making.
* Participating in the Tier process and team meetings, providing updates of department activities and status.
* Ensuring inspection readiness as well as preparing for and responding to audits, including audit findings.
* Partnering with cross-functional teams to troubleshoot, investigate and drive risk analysis and issue resolution of equipment/process issues discovered during validation studies.
* Supporting on time completion of investigations, deviations, regulatory commitments and CAPAs (corrective/preventative actions).
* Helping in identifying opportunities to improve validation processes and practices; supporting implementation of improvements to technical and business processes. Working collaboratively with cross-functional teams to ensure realization of necessary changes in a timely and productive manner.
* Maintaining compliance with all on-the-job training, applicable standard operating procedures, safety and cGMP regulations and expectations.
* Learning, displaying and maintaining the concepts of inclusive behavior, as well as striving to develop the defined Merck Leadership Standards.
Qualifications
Education:
* Required: Bachelor's degree in one of the Engineering, Sciences or Technical disciplines.
Required Experience:
* Zero to two (0 to 2) years prior experience in biological/pharmaceutical/chemical manufacturing environment.
* Working knowledge of Microsoft Outlook, Internet Explorer, Excel, Word, PowerPoint.
* Strong written and oral communication skills as necessary for documentation authoring, conducting meetings and creating / delivering presentations.
* Solid interpersonal skills involving ability to work effectively cross-functionally and cross-culturally.
Preferred Experience:
* Self-starter.
* Interested in making a contribution to the company while learning validation and other activities required for companies to be compliant with regulatory agency regulations and company expectations.
* Technical skills include working knowledge of basic engineering/scientific principles and engineering/scientific research methods; Planning and executing; problem identification and resolution; Excellent mathematical skills, knowledge of basic statistics.
* Ability to work well with others, exhibiting teamwork skills.
* Ability to handle diverse tasks and assignments, concurrently.
* Good reasoning ability and mathematical aptitude.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
merck.com/careers to create a profile and your resume for requisition # MAN001407.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Primary Location: US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Shift (if applicable)
: 1st
Hazardous Materials
: Acids used for Swab Sampling
Details:
Job Id:
34158896
Posted / Updated:
2/21/2012 3:57:02 AM
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