DescriptionThe Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. This role is responsible for ensuring validation protocols, risk assessments, PPQ studies, and CPV programs meet applicable regulatory expectations and internal procedures, while taking direct, hands-on ownership of protocol design, execution, lifecycle documentation, and ongoing process monitoring.
Essential Job Functions:- Provide QA oversight and approval of process validation activities of aseptically filled drug product across all three stages of the process validation life cycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
- Review and approve process validation life cycle documents including risk assessments, process flow diagrams, critical process parameter (CPP) and critical quality attribute (CQA) identification, validation protocols, and summary reports.
- Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
- Oversee process-related change controls to ensure appropriate revalidation assessments are performed, documented, and closed in a timely manner.
- Participate in the development, review, and revision of process validation-related SOPs, policies, and guidance documents.
- Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to process validation activities.
- Support deviation investigations and CAPA activities related to process validation, PPQ, and continued process verification; review and approve deviations associated with process validation
- Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to process validation, including FDA's 2011 Process Validation Guidance, EU Annex 15, and ICH Q8-Q12.
Special Job Requirements:- Bachelor's degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline).
- Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in process validation activities.
- Demonstrated hands-on experience in designing and executing process validation protocols, including Process Performance Qualification (PPQ) studies, for aseptically filled drug product.
- Working knowledge of the three-stage process validation life cycle as defined in the FDA 2011 Process Validation Guidance, including Process Design, Process Performance Qualification, and Continued Process Verification.
- Direct experience with critical process parameter (CPP) and critical quality attribute (CQA) identification, statistical process monitoring, and process capability analysis. Familiarity with NOR/PAR determination, and other process design and qualification using ICH Q8 methodology.
- Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to process validation (e.g., FDA Process Validation Guidance, EU Annex 15, ICH guidances; PDA and ISPE Process Validation and Technology Transfer guidances).
- Familiarity with technology transfer activities and the associated process validation requirements for new product introductions.
Additional Preferences:- Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
- Experience with aseptic processing validation, including media fills, hold time studies, shipping validation, and container closure integrity testing.
- Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities.
- Working knowledge of statistical tools and software used for process capability analysis, control charting, and continued process verification trending (e.g., Minitab, JMP).
- Experience authoring or reviewing Annual Product Quality Reviews (APQRs) or Product Quality Reviews (PQRs) as part of continued process verification programs.
