Senior Quality Validation Specialist - PPQ

Essential Job Functions

• Provide Quality Assurance oversight and approval of process validation activities for pharmaceutical manufacturing processes across all stages of the validation lifecycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
• Review and approve validation lifecycle documentation, including risk assessments, process characterization studies, process flow diagrams, critical process parameter (CPP) and critical quality attribute (CQA) assessments, validation protocols, and final reports.
• Ensure process validation activities are conducted in compliance with applicable regulatory requirements, industry standards, and internal quality procedures.
• Review and assess process‑related change controls to determine validation impact, requalification requirements, and appropriate implementation strategies.
• Support the development, review, and maintenance of validation‑related procedures, policies, and quality system documentation.
• Serve as a Quality representative and subject matter expert during internal audits, client audits, and regulatory inspections related to validation programs.
• Review and approve deviations, investigations, and CAPAs associated with process validation and ongoing process monitoring activities.
• Support cross‑functional teams in establishing and maintaining a robust process validation strategy throughout the product lifecycle.
• Remain current with evolving regulatory expectations, industry guidance documents, and best practices related to process validation and lifecycle management.

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biochemistry, or a related scientific discipline.
• Minimum 5 years of experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments with direct involvement in process validation activities.
• Demonstrated experience authoring, reviewing, or approving process validation protocols and reports, including PPQ studies.
• Strong understanding of lifecycle process validation principles, including Process Design, Process Performance Qualification, and Continued Process Verification.
• Experience identifying and evaluating critical process parameters (CPPs), critical quality attributes (CQAs), and process risks using science‑ and risk‑based approaches.
• Working knowledge of applicable regulatory requirements and industry guidance related to process validation and quality systems.
• Experience supporting process changes, validation assessments, and continuous process improvement initiatives.
• Strong technical writing, problem‑solving, and cross‑functional collaboration skills.
• Experience in sterile manufacturing, aseptic processing, biologics, injectable products, or other highly regulated production environments.
• Familiarity with technology transfer, process characterization, and commercial product launch activities.
• Experience supporting regulatory inspections and customer audits.
• Knowledge of statistical tools used for process monitoring, capability analysis, and trending (e.g., Minitab, JMP).
• Experience supporting Annual Product Reviews, Product Quality Reviews, or continued process monitoring programs.
• Previous involvement in process validation activities for commercial pharmaceutical products.