Pfizer Technical Expert, Clinical Manufacturing, Fermentation in Andover, Massachusetts
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This Technical Expert will coordinate and lead production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.
The initial focus of this role will be part of the Fermentation suite startup team to prepare the facility for operational readiness. This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, batch records, and standard work. May also include commissioning and qualification of process equipment.
Lead manufacturing operations on the production floor.
Ensure all safety and compliance procedures are followed at all times.
Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
Serve as SME for Fermentation cell culture operations.
Provide training to manufacturing staff on process and equipment.
Own Non-Conformances (NC) and Corrective and Preventive Actions (CAPA), facilitate the drive towards continuous improvement in all Manufacturing areas.
Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
Participate in the design, development, and implementation of processes in support of the manufacturing floor.
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 5+ years of experience in a biotechnology manufacturing or laboratory environment.
Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting
Prior experience of mammalian cell culture and/or microbial fermentation, harvest, chromatography and TFF processes.
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.)
Experience with Quality Management and Change Management Systems (i.e. Trackwise)
Ability to follow Standard Operating Procedures and work under minimal supervision.
Strong mechanical aptitude and ability to interface with computerized systems required.
Demonstrated capability to work as a team member in a matrix manufacturing team.
Excellent verbal and written communication skills
ADDITIONAL OFFER DETAILS
Last Day to Apply: September 19, 2019
Additional Location Information: Andover, MA
Eligible for Employee Referral Bonus: Yes
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1 (First Shift) (United States of America)
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