Pfizer Tech Associate, Clin Manufacturing, Upstream (2nd Shift) in Andover, Massachusetts
The clinical manufacturing Technical Associate is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
Creation and revising of necessary cGMP documentation, and training within the production manufacturing area.
The successful candidate will be a part of a team responsible for the execution of upstream mammalian and microbial processes.
Execute upstream mammalian cell culture and microbial fermentation processes in a cGMP environment. Includes CIP and SIP operations.
Execute product change over activities with the guidance of process engineer and tech transfer team.
Execution of SOP's and batch record documentation of upstream unit operations.
Cross-functional communication with tech transfer team, quality and engineering as necessary.
Cross-shift communication with 1st shift. Actively participates in shift exchange activities and communication channels.
Active participant of the OWN IT culture. Identifies and supports continuous improvement initiatives. Utilizes continuous improvement and root cause analysis tools ( 5S and DMAIC)
Maintains a safe work environment.
Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.)
HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.
Requires a minimum 0-3 years of experience in a biotechnology manufacturing or laboratory environment.
Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting
Knowledge of mammalian cell culture and/or microbial fermentation processes.
Familiarity with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)
Ability to follow Standard Operating Procedures and work under minimal supervision.
Fundamental mechanical aptitude and ability to interface with computerized systems required.
Demonstrated capability to work as a team member in a matrix manufacturing team.
Excellent oral and written communication skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a 2nd shift position (3-11:30p)
Ability to work occasional weekends as needed; non-routine
Ability to work in a clean room environment
ADDITIONAL OFFER DETAILS
Last Day to Apply: November 20, 2019
Additional Location Information: Andover, MA
Eligible for Employee Referral Bonus: Yes
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