Senior Quality Process Validation Specialist

Senior Quality Process Validation Specialist

About the role

Join our growing team at INCOG BioPharma, a contract development and manufacturing organization (CDMO) focused on providing comprehensive services from drug development through drug manufacturing. We are seeking a Senior Quality Process Validation Specialist to provide QA oversight of process validation activities across the full validation life cycle.

Responsibilities

• 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.
• 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.

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.
• 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.

Qualifications

• 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.

Benefits

• Paid vacation days, amount based on tenure, and paid sick time
• 11 observed holidays
• 401(k) plan with company match up to 3.5% of salary, vested immediately
• Choice of health and wellness plans
• FSA and HSA programs
• Dental and vision care