Senior Validation Engineer – Pharma Quality & Compliance

Pfizer; Rochester (MI); On-site; USD 83,000 - 138,000; Full time

Job summary

Pfizer in the United States (Michigan, Rochester) is seeking a Senior Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer quality standards.

You will troubleshoot validation issues, conduct statistical analyses, guide document writing, manage Change Control and Investigations, and support regulatory audits and product transfers. The role requires strong GMP knowledge and collaboration across teams.

Qualifications

• Minimum requirements include 8+ years with HSD, 6+ years with an Associate’s, or 2+ years with a BA/BS; advanced degrees optional.
• Proven GMP expertise and familiarity with QA systems and regulatory expectations.
• Strong written/verbal communication and ability to work independently or in teams.
• Experience with regulatory audits and compliant documentation practices.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports to ensure regulatory compliance.
• Troubleshoot validation issues for equipment and processes and provide data-driven resolutions.
• Conduct statistical analysis of testing results and support Quality Investigations.
• Guide writing, review, and approval of validation documents and technical reports.
• Manage Quality systems like Change Control and Investigations; coordinate testing with groups.
• Support regulatory audits, product transfers, and regulatory queries; participate in deviation investigations.

Skills

GMP Expertise

Quality Systems Knowledge

Analytical Skills

Communication Skills

Teamwork

Regulatory Compliance

Education

High school diploma or equivalent

Associate’s degree

BA/BS in related field

MBA/MS with any years

Tools

Global Document Management System

SAP / System Applications & Products

Quality Tracking System

Job description

Pfizer in the United States (Michigan, Rochester) is seeking a Senior Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer quality standards.

You will troubleshoot validation issues, conduct statistical analyses, guide document writing, manage Change Control and Investigations, and support regulatory audits and product transfers. The role requires strong GMP knowledge and collaboration across teams.