FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By 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 realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

• Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
• Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
• Drafts and implements validation protocols
• Coordinates the execution of validation activities (e.g., equipment set up, material readiness, and work orders)
• Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
• Executes validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
• Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
• Identifies potential risks and escalates to senior engineers or management for resolution
• Creates, implements, and maintains equipment and system qualifications and validation protocols
• Prepares and presents report packages for implementation into standard operating procedure (SOPs)
• Prepares validation master plans for facilities, equipment, and systems
• Other duties, as assigned

• Bachelor’s degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

• Master’s degree in Engineering with no prior experience
• Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
• Prior experience with mammalian cell culture process