Engineer 3, Process Validation
About The Position
The Engineer or Scientist 3 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure 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.”
Requirements
- Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 5 years of relevant experience (e.g., engineering); or Master’s degree in Engineering, Life Science or Chemical Engineering with 3 years of relevant experience (e.g., engineering); or PhD with no prior experience
- Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
- Experience using Risk Management and RCA tools
Nice To Haves
- Experience working in a Good Manufacturing Practices (GMP) environment
- Prior drug substance manufacturing experience, including process validation
- Experience with regulatory audits, inspections and requirements, such as FDA 21 CFR part 11
Responsibilities
- Ensures regulatory compliance, assesses change notifications, and provides input on process validation related matters
- Supports the team with process validation requirements
- Plays a role in developing process validation strategy and executes 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 (PQ) execution and assessments for at-scale process validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)
- Provides support to process sub-teams throughout the phases of technology transfer (TT)
- Generates 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.
- Contributes to the development and implementation of training for manufacturing staff on process validation requirements
- Facilitates troubleshooting, conducts process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed
- Supports 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)
- 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
- Participates in continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
- Other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
