What are the responsibilities and job description for the Engineering - Process Engineer position at Infobahn Softworld Inc?
Job Description: The Tech Transfer Engineer II will be joining the Pfizer Andover Clinical Manufacturing Facility (ACMF) team.
The ACMF is a facility located on the Pfizer Andover, MA campus and is responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The ACMF resides within the Research and Development organization.
The ACMF Tech Transfer Team is responsible for incoming product site assessment, preparatory activities, campaign readiness, and overall product/project ownership to support ACMF manufacturing of clinical drug substance.
Job Responsibilities
Execute tech transfer activities in support of all ACMF campaigns
Work with development lines to improve scale up processes and identify best TT practices
Partner with development lines on complex technical initiatives
Lead/support the creation of manufacturing batch records and other GMP documentation
Execute and troubleshoot upstream and downstream processes in a cGMP environment
Authorship of SOP’s for upstream and downstream unit operations
Data analysis and communication/collaboration with tech transfer team, production operations, development labs, and quality
Support implementation of new technologies and equipment
Support and author investigations as needed
Support facility audits as needed
Minimum: BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent 2 years of experience
or
MS 0 years of experience.
Preferable: BS/BA 3-5 years, MS 1-2 years
Schedule: Hybrid 2.5 days onsite / Monday – Friday / First Shift
Interview: Teams Meeting
The ACMF is a facility located on the Pfizer Andover, MA campus and is responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The ACMF resides within the Research and Development organization.
The ACMF Tech Transfer Team is responsible for incoming product site assessment, preparatory activities, campaign readiness, and overall product/project ownership to support ACMF manufacturing of clinical drug substance.
Job Responsibilities
Execute tech transfer activities in support of all ACMF campaigns
Work with development lines to improve scale up processes and identify best TT practices
Partner with development lines on complex technical initiatives
Lead/support the creation of manufacturing batch records and other GMP documentation
Execute and troubleshoot upstream and downstream processes in a cGMP environment
Authorship of SOP’s for upstream and downstream unit operations
Data analysis and communication/collaboration with tech transfer team, production operations, development labs, and quality
Support implementation of new technologies and equipment
Support and author investigations as needed
Support facility audits as needed
Minimum: BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent 2 years of experience
or
MS 0 years of experience.
Preferable: BS/BA 3-5 years, MS 1-2 years
Schedule: Hybrid 2.5 days onsite / Monday – Friday / First Shift
Interview: Teams Meeting
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