Process Engineer 2, Visual Inspection

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us deliver the next vaccine, cure, or therapy in a dynamic work environment that fuels purpose, energy, and drive.

About the role

As a Process Engineer 2 supporting Drug Product Finished Goods (DPFG) within Visual Inspection, you will provide engineering guidance to stakeholders across capital projects, technology transfer, and manufacturing operations. This role ensures processes are efficient, scalable, and compliant with Current Good Manufacturing Practice (CGMP) regulations while optimizing plant efficiency and reliability. You will leverage experience with automated systems, including camera and vision-based inspection systems for pharmaceutical products.

Responsibilities

• Serve as the point of contact for the Engineering, Procurement, Construction Management (EPCM) provider.
• Secure on-time delivery and ensure quality from the Fujifilm EPCM provider for equipment packages with limited complexity.
• Develop and align basic plans, providing mitigations as needed.
• Review piping and instrumentation diagrams (P&IDs) and other process design documents.
• Provide direction to detailed design activities in partnership with the EPCM provider.
• Write User Requirements Specifications (URSs).
• Support Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities.
• Serve as on-call support for process equipment.
• Review, redline, and approve P&IDs and other technical documents with limited supervision.
• Perform system impact assessments and quality risk assessments for process equipment.
• Perform technology transfer (TT) activities related to process equipment.
• Support execution of Good Manufacturing Practices (GMP) runs.
• Provide technical support for root cause analysis (RCA) and process deviation investigations.
• Lead or assist with deviations, change controls, and corrective and preventive action (CAPA) closures.
• Make decisions regarding technical risk assessments for new manufacturing equipment.
• Provide on-floor manufacturing support for equipment issues.
• Provide process equipment training and consultation within assigned areas.
• Support continuous improvement projects in partnership with Maintenance and Manufacturing.
• Cross-train on multiple unit operations to assist the team with achieving deliverables.
• Collaborate with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Chemical or Biotechnology Engineering, or a related field with 2 years of Engineering experience; or a Master’s degree in Chemical or Biotechnology Engineering with no prior experience.
• Experience in a Life Science or other regulated industry.
• Experience with Engineering drawings and using Quality Systems (e.g., deviation management, change control, CAPA, document management system).

Preferred Qualifications

• Prior experience working in a cGMP environment or other highly regulated industry.
• Experience working in at least one unit operation in a pharmaceutical or Life Science environment.
• Prior experience with mammalian cell culture processes.