Senior Validation Engineer
Pfizer · Rochester, MI
QualityFull-time$83k–$138kCompany career page
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Role summary
Senior Validation Engineer responsible for planning and executing validation projects for manufacturing processes, equipment, and utility systems at a pharmaceutical facility. Develops validation documentation, conducts gap assessments, and ensures regulatory compliance throughout the product lifecycle.
What they're looking for
- High school diploma with 8+ years experience, or associate's degree with 6+ years, or bachelor's degree with 2+ years
- Demonstrated expertise in Good Manufacturing Practices and quality systems
- Proficiency with document management, enterprise resource planning, and quality tracking systems
- Excellent verbal and written communication abilities
- Ability to work independently and collaboratively in team settings
- Physical capability to lift minimum 30 pounds, work in controlled environments, use ladders
What you'll be doing
- Plan, schedule, and execute validation and qualification activities for manufacturing equipment, processes, and utilities
- Develop and author validation protocols, master plans, and lifecycle documents including FAT, SAT, DQ, IQ, OQ, and PQ
- Conduct process capability analysis and perform gap and risk assessments on commercial processes
- Support corrective actions, investigate deviations, and lead implementation of process improvement projects
- Coordinate cross-functionally to complete validation activities and prepare for regulatory audits
Privacy & handoff
This role links to Pfizer's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.