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SOKOL GxP Services is seeking a Junior MSAT Process Engineer to support OOS investigations within a GMP-regulated manufacturing environment. You will review batch records, process data, and analytical results to help develop sound investigation findings and conclusions.
The role requires collaboration across Quality Assurance, Quality Control, Manufacturing, and Engineering, with investigation ownership as appropriate and an on-site/hybrid work arrangement in Devens, MA.
The Junior MSAT Process Engineer will support Manufacturing Science and Technology activities with a primary focus on Out-of-Specification (OOS) investigations within a GMP-regulated manufacturing environment.
The role will support OOS investigations by reviewing batch records, process data, equipment logs, and analytical results and helping develop technically sound investigation findings and conclusions. Investigation ownership may be assigned as appropriate.
The engineer will work cross-functionally with Quality Assurance, Quality Control, Manufacturing, and Engineering to gather data, align on investigation scope, and present investigation findings and technical rationale to cross-functional teams and management.
Strong GMP experience is important for this position. Pharmaceutical or biopharmaceutical industry experience is preferred.