Manager, Process Validation & Verification

PPD (Thermo Fisher)

St. Louis, United States
On-site
Process validation (ppq) and continued process verification (cpv)
Site validation lifecycle execution and governance
Cross-functional partnership with msat, manufacturing, quality
Thermo Fisher Scientific is seeking a Manager for Process Validation & Verification at their St. Louis facility. The role focuses on providing technical leadership in process validation and compliance, requiring extensive experience in biopharmaceutical manufacturing and people management

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: 85

Thermo Fisher Scientific is seeking a Manager for Process Validation & Verification at their St. Louis facility. The role focuses on providing technical leadership in process validation and compliance, requiring extensive experience in biopharmaceutical manufacturing and people management.

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
  • Adherence to GMP Safety Standards
  • Experience with FDA, EMA, and ICH guidance

Nice-to-have

  • Strong statistical knowledge
  • Lean/Six Sigma certification
  • Client discussions related to validation

Key Requirements

  • Bachelor's degree in Engineering, Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline
  • 8+ years of experience in biopharmaceutical manufacturing, MSAT, process engineering, validation, or related technical function
  • 2+ years of formal or informal people leadership experience
  • Working knowledge of FDA, EMA, and ICH guidance related to process validation
  • Legally authorized to work in the United States

Work Rights

Not specified

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