Validation Specialist (PERM) - Biopharmaceutical
FPCNational - Massachusetts

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Engineering Validation Department seeks validation specialists to lead aspects of utilities validation, cleaning and sterilization and equipment requalification’s in this biotechnology and biologics leader.

The Top Challenges:
1) Perform validation in GMP Biotech manufacturing facility
2) Lead validation processes and/or contractors in the areas of Sterilization Validation, SIP, CIP and Cleaning Validation
3) Provide similar expertise as related to Kaye / GE Validator
4) Generate and execute protocols for cell culture and purification equipment
5) Coordinate validation testing with other departments and manage small and medium size projects
6) Availability during 2nd and 3rd shifts when necessary.

Salary: Base will be dependent on your expertise and should range from the 70’s to the 80’s. Also available is strong benefits, bonus and relocation
Location: Massachusetts
Contact: Apply below and/or at and/or contact Ira Mann at

1) 3+ years of validation experience with at least half (and preferably recent) being in biologics, biotechnology or biopharmaceutical.
2) BS Degree in Engineering or Science
3) Experience using risk based approach or (FMEA, PHA, etc) in validation
4) Experience with cell culture or purification processes (preferred)
5) ASTM E2500 knowledge
6) Project management experience
7) Experience with operating a Kaye / GE validator (preferred)

Key Words: equipment validation, requalification, sterilization validation, SIP, cleaning Validation, CIP, COP, Kaye, GE validator, biologics, biotechnology, biopharmaceuticals, bioreactors, cell culture, purification, autoclaves