Process Engineer - Validation - (US-NC-Durham - 27722)

Minimum Education: Tech School
Job Type: Full Time
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Merck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.

Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Part of the Global Vaccine Technology & Engineering (GVTE) organization Viral Vaccine Technology & Engineering (VVTE) is seeking a highly motivated individual to partner with Operations Merck Research Laboratories Quality Operations Bio-Sterile Validation and the Regulatory groups to meet the targeted manufacturing and compliance initiatives within Viral Vaccine Manufacturing. Viral VTE provides technical support for the manufacture of Mercks cell-culture based vaccines: VARIVAX (Chicken Pox Vaccine) ZOSTAVAX (Shingles vaccine) M-M-RII (Measles Mumps and Rubella vaccine) VAQTA (Hepatitis A Vaccine) and ROTATEQ (Rotavirus Vaccine).

Positions are responsible for validation activities associated with the start-up qualification and validation of a new vaccine bulk manufacturing facility at the Durham North Carolina site. Position involves activities associated with equipment sterilization cleaning and process validation efforts providing technical support to help develop and execute validation project plans. Obtains and analyzes relevant data and prepares appropriate reports for regulatory commitments and validation improvement initiatives. May be responsible for leading teams to efficiently accomplish project goals.

Primary activities include but are not limited to the following:

1. As directed maintains a resident liaison function with Operations Quality and MRL. Maintains alignment with internal technical personnel regarding products equipment and processing techniques.
2. Leads execution of validation activities for both new and inline products.
3. Assist in segments of technology transfer for new products or unit operations including CIP/SIP/process design and process equipment specification in support of validation activities.

Required:B.S. in Engineering or Biological Sciences
Minimum of 6 years Process Engineering or Production Operations with at least 4 years of validation experience in one or all of the following areas: Process Equipment Sterilization Cleaning
Demonstrated leadership potential project management strong communication and teamwork skills.Preferred:

Experience in GMP biologics manufacturing including preparation of validation protocols and regulatory submissions and participation in regulatory inspections
Experience with matrix organizations
Previous experience with new facility construction and qualification activities.

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