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Description
Process Engineer-PRO007736
Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
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.
Merck's Biological Sterile Validation Responsible (BSV) department, located in West Point, PA, is currently seeking a Process Engineer. BSV's responsibilities include providing documented evidence that processes are consistent and reliable through challenges against pre-established criteria for all vaccines (worldwide) and sterile pharmaceuticals (West Point). Incumbent will support validation activities associated with the development of new products, processes, systems, and facilities and support of existing products, processes, systems, and facilities.
Position involves validation activities associated with the manufacture of multiple bulk vaccine products. Incumbent will provide technical support to help develop and execute project plans. Obtains and analyzes relevant data and prepares appropriate reports for regulatory commitments and validation improvement initiatives. May be responsible for leading a small team to efficiently accomplish project goals.
Primary activities include, but are not limited to the following:
* Applies technical expertise to advance business goals through the application of appropriate technologies.
* As directed, maintains a resident liaison function with Operations, Quality, and Merck Research Labs (MRL). Maintains alignment with internal technical personnel regarding products, equipment, and processing techniques.
* Leads execution of validation activities for both new and inline products.
* Leads segments of technology transfer for new products or unit operations from MRL including CIP/SIP/process design and process equipment specification in support of validation activities.
* Independently troubleshoots and effectively resolves manufacturing problems. Develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply of vaccines and sterile products.
* Provides contributions to the planning, design, and implementation of segments of new or upgraded process facilities and equipment in a cost effective and timely manner.
* As required, supervise and guide technical staff.
* Prepares and/or provides review and guidance for regulatory filings, process descriptions, atypical process reports, and change requests.
Qualifications
Education:
* B.S. in Chemical Engineering or Biological Sciences plus a minimum of 5 years relevant experience required. Prefer M.S./Ph.D. in Chemical Engineering or Biological Sciences with a minimum of 3 years related experience
Required:
* Experience with Cleaning Validation and Sterile Validation
* Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills.
* Experience leading a team
* Experience working in the pharmaceutical industry
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 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
Details:
Job Id:
754658A0
Posted / Updated:
4/8/2010 3:32:33 AM
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