Sr. Engineer 1, Process Validation

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Senior Engineer or Scientist of Process Validation 1 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.”

Responsibilities

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)
Supports process sub-teams throughout the phases of technology transfer (TT)
Leads generation of sampling plans for process validation reports (PVRs) and investigations
Writes and reviews documentation for internal and external use, such as validation campaigns summary reports, PPQ protocol and reports, impact assessments, etc.
Develops and implements training for manufacturing staff on process validation requirements
Leads or supports troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed
Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes for manufacturing readiness (e.g., acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for proposed changes)
As technical SME, leads or supports generation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements
Other duties, as assigned