Process Engineering Tech I

Senior Process Engineer
Pharmaceutical / Biopharmaceutical Manufacturing

Focus: Fill/Finish Technology Transfer & Validation

Our client is seeking a Senior Process Engineer to lead and execute a large-scale fill/finish technology transfer within a pharmaceutical manufacturing environment. This is a senior, hands-on engineering role requiring the ability to assess existing site processes and documentation, identify gaps, and drive the technology transfer from initial site intake through execution The Senior Process Engineer will provide technical leadership, process control strategy, validation strategy, and batch execution support , while working closely with cross-functional teams and external stakeholders. Dedicated document-writing support will be provided; however, the engineer will be responsible for providing the technical content and direction for protocols, reports, and supporting documentation. Lead large-scale fill/finish technology transfer activities from site intake through implementation and execution.
Review and assess existing process documentation, batch records, manufacturing procedures, and technology transfer documentation to identify gaps and drive resolution.
Develop and define the process control strategy in support of technology transfer, process validation, and commercial manufacturing readiness.
Lead and support engineering batches, PPQ batches, validation batches, and manufacturing execution activities .
Develop and own the overall process validation strategy , providing technical direction and content to supporting validation teams.
Provide technical guidance and source content to document writers for validation protocols, reports, batch documentation, technology transfer documents, and related deliverables .
Evaluate manufacturing processes, identify technical risks, and recommend solutions to ensure successful technology transfer.
Partner with Manufacturing, Quality, Validation, Engineering, MSAT, and other cross-functional teams to align on technical requirements and execution plans.
Track technology transfer activities, identify project risks and gaps, and drive technical actions through completion.
Serve as the technical lead and primary point of accountability for successful fill/finish technology transfer execution.
Provide hands-on technical support during manufacturing and validation activities and troubleshoot process issues as needed.
Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related technical discipline .
Strong experience in pharmaceutical or biopharmaceutical manufacturing , preferably within drug product operations.
Significant experience with fill/finish manufacturing and technology transfer .
Hands-on experience supporting process validation, PPQ, engineering batches, and validation batches .
Strong understanding of process control strategy and manufacturing process development .
Experience reviewing and assessing batch records, process documentation, technology transfer packages, and manufacturing procedures .
Strong knowledge of GMP/cGMP requirements and pharmaceutical manufacturing practices .
Experience working cross-functionally with Manufacturing, Quality, Validation, Engineering, MSAT, and external stakeholders .
Experience with aseptic processing or sterile manufacturing .
Experience leading large-scale technology transfers .
Experience supporting commercial-scale pharmaceutical manufacturing operations.