Pfizer Technical Associate, Clinical Manufacturing, Downstream in Andover, Massachusetts
The Technical Operations II, Clinical Manufacturing associate is part of a multi-disciplinary team responsible for cGMP production of Phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
Initial focus is on the start-up of a new facility in support of suite/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production operation area.
Post facility start up, the successful candidate will remain on 1st shift. The successful candidate will be a part of a dynamic team responsible for the execution of downstream mammalian and microbial processes.
Execute downstream mammalian and microbial purification 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 downstream unit operations.
Cross-functional communication with tech transfer team, quality and engineering as necessary.
Cross-shift communication with 2nd 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.
Must be able to climb flights of stairs, and be standing for 1-2 hours at a time.
Must be able to lift up to 25lb
Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work off shift (Weekends) as needed; non-routine
Ability to work in a clean room environment
Other Job Details:
Last Date to Apply for Job: December 31, 2018
Additional Location Information: Andover, MA
Eligible for Employee Referral Bonus: Yes
EEO & Employment Eligibility
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