Process Engineer I, Drug Product

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Process Engineer I provides engineering guidance for capital projects, technology transfer, and manufacturing operations, helping ensure compliance with safety, regulatory, and engineering requirements. The role supports product and customer requirements and works toward improving plant efficiency and profitability. The engineer supports design and documentation activities with an Engineering, Procurement, and Construction Management (EPCM) provider; assists with factory acceptance testing, commissioning, qualification, validation, and start-up under supervision; and provides technical support for process equipment and manufacturing operations. The position also contributes to GMP execution, investigations, risk assessments, and cross-functional work with Quality, Manufacturing, Maintenance, Validation, and Safety teams. This role is based at Fujifilm Biotechnologies’ biopharmaceutical manufacturing facility in Holly Springs, North Carolina. The work may involve production and mechanical spaces, respiratory or hearing protection, enclosed spaces, heights, and varied warm or cold environments. The employee must be able to meet the listed physical demands, with reasonable accommodations available for individuals with disabilities.

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 and in mechanical or production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues; ascend and descend ladders, scaffolding, and ramps; stand for up to 120 minutes; and sit for up to 240 minutes.
Ability to perform repetitive motions involving wrists, hands, or fingers; operate machinery or power tools; and move objects up to 33 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
Ability to work in warm or cold environments (60–90 range), small or enclosed spaces, and at 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 EPCM 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, Safety, and other departments.
Perform other duties as assigned.