OverviewThe 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.
External USWhat You'll Do- 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
Minimum Requirements:- Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., engineering); or
- Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience (e.g., engineering);
or
Preferred Requirements:- Prior drug substance or manufacturing experience, including expertise in new product launch, process validation and commercialization
- Experience with regulatory audits and inspections and regulatory requirements such as FDA 21 CFR part 11
- Experience supporting or writing portions of regulatory filings
Physical and Work Environment Requirements:- 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.
