Pfizer Associate Engineer, Clinical Manufacturing in Andover, Massachusetts
The clinical manufacturing operations engineer 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 facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training of operations staff.
Post facility start up, the successful candidate will transition to 2nd shift to be part of a team that will be responsible for the execution of upstream mammalian and microbial processes.
Execute and troubleshoot upstream mammalian cell culture and microbial fermentation processes in a cGMP environment. Includes support and troubleshooting of CIP, SIP operations.
Lead/support tech transfer activities for new products and product changeover for operations team
Authorship of and execution against SOP's for upstream unit operations
Lead/support the creation of manufacturing batch records and other cGMP documentation
Data analysis and communication/collaboration with tech transfer team, development labs and quality
Training of operations colleagues
Support implementation of new technologies and equipment
Support investigations and audits as needed
BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent
0-2 years of experience in a laboratory or manufacturing environment
Knowledge of mammalian cell culture and/or microbial fermentation processes
Experience with operation of single use systems.
Experience 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 execute against SOP's and document entries in a compliant manner
Demonstrated capability to work as a team member in a matrix manufacturing team
Excellent oral and written communication skills
Ability to work under minimal supervision
Must be able to climb flights of stairs, and remain standing for 1-2 hours
Must be able to lift up to 50 lbs
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a 2nd shift position, however during commissioning and start up, the candidate will work 1st shift hours. Once the facility is operational, the candidate will transition to 2nd shift.
Ability to work off shift (Nights and Weekends) as needed; non-routine
Ability to work in a clean room environment
EEO & Employment Eligibility
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Other Job Details:
Last Date to Apply for Job: July 1, 2018
Eligible for Employee Referral Bonus: yes
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.