Process Engineer 3
1 month ago
The Process Engineer 3 plays a crucial role in supporting capital projects, technology transfer, and manufacturing operations at FUJIFILM Diosynth Biotechnologies. This position ensures compliance with all safety, regulatory, and engineering requirements, adhering to product and customer demands while optimizing plant efficiency and profitability.
Key Responsibilities- Collaborate with the Engineering, Procurement, Construction Management (EPC) provider to ensure timely delivery and quality of moderate complexity equipment packages.
- Develop and align plans, providing mitigations as needed, and review piping and instrumentation diagrams (P&IDs) and other process design documents.
- Provide direction to detailed design activities in partnership with the EPCM provider and write User Requirement Specifications (URSs).
- Support Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities, serving as on-call support for process equipment.
- Review, redline, and approve P&IDs and other technical documents as the technical authority, leading system impact assessments and quality risk assessments for process equipment.
- Perform technology transfer (TT) activities related to process equipment and support execution of Good Manufacturing Practices (GMP) runs.
- Provide technical support for root cause analysis (RCA) and process deviation investigations, leading or assisting with deviations, change controls, and corrective and preventive action (CAPA) closures.
- Make decisions regarding technical risk assessments for new manufacturing equipment and provide on-floor manufacturing support for equipment issues.
- Provide process equipment training and consultation on topics within assigned areas and participate in identifying continuous improvement projects within unit operations to improve manufacturability, reliability, yield, and cost.
- Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or Master's in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience.
- Experience in Life Science or other regulated industry, with experience working in a cGMP environment or other highly regulated industry preferred.
- Experience working in harvest unit operations (Centrifugation, Filtration) in a pharmaceutical or Life Science environment, with experience with mammalian cell culture processes preferred.
The Process Engineer 3 will work in a dynamic environment, with the ability to ascend or descend ladders, scaffolding, ramps, etc. The role requires standing for prolonged periods up to 120 minutes, sitting for up to 240 minutes, and conducting activities using repetitive motions. The ability to operate machinery and/or power tools, move objects up to 33 pounds, bend, push or pull, reach to retrieve materials from 18" to 60" in height, and using twisting motions is also required. The role may involve working in warm/cold environments, small and/or enclosed spaces, and heights greater than 4 feet.
FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
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