Process Engineer I, Drug Product

Fujifilm•Holly Springs, NC

3d•Onsite

About The Position

The Process Engineer I, Drug Product, provides engineering guidance for capital projects, technology transfer, and manufacturing operations, ensuring compliance with safety, regulatory, and engineering requirements. The role supports product and customer requirements while helping optimize plant efficiency and profitability. The position supports process equipment design and documentation, factory acceptance testing, commissioning, qualification, validation, start-up, technology transfer, and GMP manufacturing runs. It also provides technical support for equipment issues, root cause analysis, process deviations, risk assessments, and corrective and preventive actions, working with departments including Quality, Manufacturing, Maintenance, Validation, and Safety.

Requirements

Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related field.
0–1 years of engineering or other relevant technical work experience.
Ability to develop effective working relationships internally.
Effective written and oral communication skills.
Basic problem-solving skills.
Basic project management skills.
Ability to present information to others.

Nice To Haves

Experience working in a cGMP environment or another highly regulated industry.
Prior experience with mammalian cell culture processes.

Responsibilities

Support on-time delivery and quality from Fujifilm and the Engineering, Procurement, and Construction Management (EPCM) provider.
Support review of piping and instrumentation diagrams (P&IDs) and other process design documents.
Provide input to detailed design activities in partnership with the EPCM provider.
Write User Requirement Specifications (URSs).
Support Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities under supervision.
Serve as on-call support for process equipment.
Review, redline, and approve P&IDs and other technical documents under supervision.
Contribute to system impact assessments and quality risk assessments for process equipment.
Support technology transfer activities related to process equipment.
Support execution of Good Manufacturing Practices (GMP) runs.
Provide technical support for root cause analysis and process deviation investigations.
Assist with deviations, change controls, and corrective and preventive action (CAPA) closures.
Support technical risk assessments for new manufacturing equipment.
Provide on-floor manufacturing support for equipment issues.
Cross-train on unit operations to help the team meet deliverables.
Collaborate with Quality, Manufacturing, Maintenance, Validation, Safety, and other departments.
Perform other duties as assigned.