Process Engineer I, Drug Product

Fujifilm•Holly Springs, NC

9h•Onsite

About The Position

The Process Engineer I provides engineering guidance for capital projects, technology transfer, and manufacturing operations, ensuring compliance with safety, regulatory, engineering, product, and customer requirements. The role supports plant efficiency and profitability and works with an Engineering, Procurement, and Construction Management provider and internal departments to support design, equipment readiness, and manufacturing operations. The position supports design document review and development, including P&IDs and User Requirement Specifications, as well as Factory Acceptance Testing, Commissioning Qualification and Validation, and start-up activities under supervision. It also supports technology transfer, Good Manufacturing Practice runs, equipment investigations and risk assessments, and on-floor manufacturing needs. The employee cross-trains on unit operations and collaborates with Quality, Manufacturing, Maintenance, Validation, and Safety teams. The role is based in a biopharmaceutical manufacturing environment in Holly Springs, North Carolina. Work may involve production and mechanical spaces, respiratory or hearing protection, enclosed spaces, heights, and a range of physical activities. Fujifilm describes its workplace culture as dynamic and purpose-driven, guided by its Genki culture and Group Purpose of “giving our world more smiles.”

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.
Ability to work in environments that may necessitate respiratory protection.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
Ability to stand for up to 120 minutes and sit for up to 240 minutes.
Ability to perform repetitive motions involving wrists, hands, and/or fingers.
Ability to operate machinery and/or power tools.
Ability to move objects up to 33 pounds.
Ability to bend, push or pull, reach for materials 18 to 60 inches high, and use twisting motions.
Ability to work in warm or cold environments in the stated 60–90 range, small and/or enclosed spaces, and heights greater than 4 feet.

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 provider.
Support review of 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 with supervision.
Serve as on-call support for process equipment.
Review, redline, and approve P&IDs and other technical documents with 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, and Safety departments.
Perform other duties as assigned.