Position OverviewJoin a mission-driven team ensuring that every batch is safe, consistent, and inspection-ready. As an Engineer/Scientist 2 on our Process Validation team, you'll help design, execute, and document robust validation strategies-partnering across Tech Transfer, Manufacturing, Quality, and Engineering to keep processes reproducible under normal operating conditions.
Job DescriptionResponsibilities- Support the team with process validation requirements across equipment, systems, and manufacturing processes
- Ensure regulatory compliance; assess change notifications related to process validation
- Contribute to process validation strategy and execute all aspects of validation, including:
- Process Performance Qualification (PPQ) runs
- Continued Process Verification (CPV)
- Other validation studies, as needed
- Collaborate with Validation/CQV to support Performance Qualification (PQ) execution and at-scale assessments (e.g., worst-case soiling for cleaning validation, microbial hold, mixing validation)
- Support process sub-teams throughout Technology Transfer (TT) phases
- Facilitate generation of sampling plans for Process Validation Reports (PVRs) and investigations
- Write and review documentation (e.g., validation campaign summaries, PPQ protocols and reports, impact assessments) for internal and external audiences
- Contribute to developing and implementing training for manufacturing staff on process validation requirements
- Support troubleshooting, process impact assessments, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) in response to critical deviations, as needed
- Support TT stage-gate reviews for manufacturing readiness (e.g., process characterization and validation, risk assessments and mitigation, robust supporting data for proposed changes)
- Support creation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, and extractables/leachables assessments; contribute to relevant site procedures and policies
- Participate in continuous improvement initiatives with Manufacturing, Quality, Engineering, and Global teams (as applicable) to improve manufacturability, reliability, yield, and cost
- Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
- Perform other duties, as assigned
Minimum Qualifications- Bachelor's degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
- Master's degree in Engineering, Life Science, or Chemical Engineering with no previous experience
Preferred Qualifications- Experience using Quality Systems (e.g., deviation management system, change control, CAPA, document management system)
- Experience using risk management and RCA tools
- Experience working in a Good Manufacturing Practices (GMP) environment
- Prior drug substance manufacturing experience, including process validation
Knowledge, Skills, and Abilities- Knowledge of regulatory audits and inspections and requirements (e.g., FDA 21 CFR Part 11)
- Understanding of GMP, GLP, and GDP requirements
- Knowledge of validation principles and techniques (IQ, OQ, PQ)
- Strong problem-solving and project management skills
- Excellent communication and teamwork skills; ability to present information clearly and adapt style to different audiences
- Ability to provide constructive feedback to peers and leaders
Working Arrangement and Environment- Hybrid eligible: Yes
- On-call eligible: No
- Typical office/lab and manufacturing support environments
- Ability to discern audible cues
- No routine requirements for respiratory protection, powered industrial truck operation, prolonged standing/sitting, repetitive motions, climbing, operating machinery, lifting thresholds, or work at heights
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.
