Pfizer Process Engineer, Tech Transfer in Andover, Massachusetts
The Process Engineer, Tech Transfer role is accountable for operational representation and delivery of the elements associated with facility/equipment or process change.
This includes tech transfer of products/ processes to and from the facility, product re-entry, and changes to improve process robustness and facility capability.
Complete site assessment including process flow diagrams, equipment selection, material planning, and operations schedule for clinical and/or commercial products to be manufactured.
Act as the operations lead for incoming campaigns to and from the suites. This work includes interface with the donating or receiving organization and operations staff. It also includes technical oversight of campaigns.
Manage change to equipment, automation, and procedures in the manufacturing area.
Author and/or reviews manufacturing batch records, solution formulation records, and standard operating procedures.
Represent operations on cross functional projects to improve performance of the site.
Drive continuous improvement in the work processes associated with tech transfer, product entry to the manufacturing area, and change management.
Bachelor's in engineering with 4 years of relevant experience is required.
or Master's in engineering with 2 years of relevant experience is required.
or Bachelor's in science with 6 years of relevant experience is required.
or Master's in science with 4 years of relevant experience is required.
Familiarity and experience with one of the following unit operations: mammalian cell culture/ bioreactor, centrifugation, tangential flow filtration, column chromatography.
Hands on experience with the above unit operations at manufacturing scale
Previous experience in a GMP manufacturing environment
Previous experience with process validation, change management, tech transfer, or project management
Previous experience with scale up of the unit operations
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs
Work will include walking throughout the manufacturing suite including up and down stairs.
An ability to cross reference multiple documents and perform a detailed review of documentation is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The role requires work in a GMP manufacturing suite which requires gowning.
The role requires occasional evening and weekend support of manufacturing operations.
Occasional travel may be required based on project assignment.
Other Job Details:
Last Date to Apply for Job: 11/30/2020
Eligible for Employee Referral Bonus
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