Process validation (ppq) and continued process verification (cpv)
Site validation lifecycle execution and governance
Cross-functional partnership with msat, manufacturing, quality
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Thermo Fisher Scientific is seeking a Manager for Process Validation & Verification at their St. Louis facility, focusing on biopharmaceutical manufacturing. The role involves leadership in process validation, ensuring compliance with regulatory standards, and fostering cross-functional partnerships to enhance operational efficiency.
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Job Summary
The Manager, Process Validation & Verification provides site-level technical and organizational leadership for process validation (PPQ) and continued process verification (CPV) activities supporting clinical and commercial biologics manufacturing.
This role serves as the site owner for validation lifecycle execution and governance, ensuring processes are qualified, monitored, and maintained in a state of control in alignment with regulatory requirements and company standards.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Manager for Process Validation & Verification at their St. Louis facility, focusing on biopharmaceutical manufacturing. The role involves leadership in process validation, ensuring compliance with regulatory standards, and fostering cross-functional partnerships to enhance operational efficiency.
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Skills & Requirements
Must-have
Process validation (PPQ) and continued process verification (CPV)
Site validation lifecycle execution and governance
Cross-functional partnership with MSAT, Manufacturing, Quality
Lead and develop validation engineers/scientists
Ensure inspection readiness for validation programs
Nice-to-have
Data-driven and continuous improvement mindset
Strong statistical knowledge
Lean/Six Sigma certification
Key Requirements
8+ years of experience in biopharmaceutical manufacturing, MSAT, process engineering, validation, or related technical function
Minimum 2+ years of formal or informal people leadership experience
Working knowledge of FDA, EMA, and ICH guidance related to process validation
Bachelor's degree in Engineering, Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline required