Engineer ; Downstream

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 cultivate a culture that fuels 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:

• Lead and support the technology transfer (TT) sub‑team activities by conducting lab and pilot plant experiments.
• Collaborate and lead the execution of sampling protocols, as directed.
• Participate in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs).
• Support training of manufacturing staff.
• Support training members of the process sciences group on the use of equipment in the lab and pilot plant areas.
• Analyze and summarize lab data for clients.
• Write process performance qualification (PPQ) protocols and reports.
• Support and lead TT within unit operations, as directed.
• Interpret and communicate results to the TT team.
• Provide technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations.
• Write reports and aid in closing out deviations.
• Provide process training and consultation on topics related to manufacturing and process.
• Provide input to technical risk assessments for new manufacturing processes.
• Contribute to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations.
• Collaborate with the manufacturing department to support commercial and clinical manufacturing campaigns, including on‑floor support.
• Support continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost.
• Manage lab equipment.
• Collaborate with colleagues to develop lab‑scale protocols.
• Execute and oversee sampling plans for lab runs.
• Serve as on‑call for lab issues and concerns.
• Other duties, as assigned.

• Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or Master’s degree with no prior experience.
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system).

• Experience working in a Good Manufacturing Practices (GMP) environment.

• Ability to discern audible cues.

To all agencies:
Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via‑email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().