Sr Engineer​/Scientist ; Upstream

Company Overview

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 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 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.”

The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

• Develop site technical training programs for new processes and procedures
• Collaborate with cross‑functional teams to support commercial and clinical manufacturing campaigns, including on‑floor support
• Lead continuous improvement projects in partnership with Manufacturing, Quality, Engineering, Global teams to improve manufacturability, reliability, yield, and cost
• Serve as SME to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
• Provide supplier technical evaluations, risk assessments, raw material evaluation and qualification, and experimental plans as required
• Identify opportunities to improve systems and practices and provide direction to local and global cross‑functional teams
• Lead one or more projects spanning multiple departments and cross‑functional areas
• Provide engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
• Lead process sub‑teams throughout the phases of TT
• Develop project plans, timelines, and communication forums to ensure a smooth transfer
• Lead troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
• Lead the execution of all aspects of process validation including ancillary process validation (both at‑scale and small‑scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
• Write, review, and approve master batch records (MBRs) and standard operating procedures (SOPs)
• Lead generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
• Generate and execute process training and consult on topics related to manufacturing and process
• Lead and facilitate technical risk assessments for new manufacturing processes
• Provide interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
• Lead and coordinate analysis of manufacturing process performance and reporting to manufacturing management
• Support development of longer‑term Large‑Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
• Deliver documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
• Other duties as assigned

• Bachelor’s degree in Engineering, Life Science or Chemical…