Sr Engineer 1, Process Validation

The Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions.

This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes.

Additionally, this role works closely with cross-functional teams to ensure that processes are consistently producing high-quality products in a safe and efficient manner.

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

• Provides oversight and supports the team with process validation requirements Ensures regulatory compliance, assesses change notifications, and provides strategic input on process validation related matters
• Develops process validation strategy and leads execution of all aspects of process validation including process performance qualification (PPQ) runs, continued process verification, and other validation studies
• Partners with Validation (CQV) to support Performance Qualification execution and assessments for at-scale process validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)