Senior Validation Engineer
Pfizer
September 02, 2026
On-site
Michigan, United States
Operations
What You Will Achieve:
- Evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.
- Troubleshoot validation issues for equipment and performance processes.
- Conduct statistical analysis of testing results and process anomalies; support Quality Investigations with high-level data analysis.
- Write, review, and approve validation process documents and technical reports per Pfizer Quality Standards.
- Contribute to moderately complex projects; plan short-term work activities.
- Manage Quality systems (Change Control, Quality Agreement, Documentation, Investigations) and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan; support regulatory audits; represent engineering validation.
- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation; integrate validation schedules into production and participate in deviation investigations.
Here Is What You Need (Minimum Requirements):
- High school diploma (8+ yrs) or associate’s (6+ yrs) or BA/BS (2+ yrs) or MBA/MS (any relevant years).
- Proven GMP expertise.
- Strong working knowledge of quality systems and processes.
- Familiarity with Global Document Management System, SAP, and Quality Tracking System.
- Excellent verbal and written communication.
- Ability to work independently and in a team.
Bonus Points (Preferred Requirements):
- Validation/qualification expertise for pharma processes/equipment/utilities/facilities/computer systems.
- Sterile products and medical devices experience.
- Strong analytical/problem-solving; organizational/time management; ability to mentor.
- Regulatory audit/compliance experience.
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) with responsible AI practices.
Physical/Mental Requirements:
- Not allergic to penicillin; must be able to aseptically gown; lift 25–30 lbs.
Schedule/Travel:
- Non-standard schedule may be required (weekends/2nd shift/night shift/calls). Minimal travel.
Work Location: On Premise
Last Date To Apply: August 14, 2026
Compensation/Benefits: Base salary $82,700–$137,900; bonus target 10%. Benefits include 401(k) with Pfizer matching, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health coverage.
- Evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.
- Troubleshoot validation issues for equipment and performance processes.
- Conduct statistical analysis of testing results and process anomalies; support Quality Investigations with high-level data analysis.
- Write, review, and approve validation process documents and technical reports per Pfizer Quality Standards.
- Contribute to moderately complex projects; plan short-term work activities.
- Manage Quality systems (Change Control, Quality Agreement, Documentation, Investigations) and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan; support regulatory audits; represent engineering validation.
- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation; integrate validation schedules into production and participate in deviation investigations.
Here Is What You Need (Minimum Requirements):
- High school diploma (8+ yrs) or associate’s (6+ yrs) or BA/BS (2+ yrs) or MBA/MS (any relevant years).
- Proven GMP expertise.
- Strong working knowledge of quality systems and processes.
- Familiarity with Global Document Management System, SAP, and Quality Tracking System.
- Excellent verbal and written communication.
- Ability to work independently and in a team.
Bonus Points (Preferred Requirements):
- Validation/qualification expertise for pharma processes/equipment/utilities/facilities/computer systems.
- Sterile products and medical devices experience.
- Strong analytical/problem-solving; organizational/time management; ability to mentor.
- Regulatory audit/compliance experience.
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) with responsible AI practices.
Physical/Mental Requirements:
- Not allergic to penicillin; must be able to aseptically gown; lift 25–30 lbs.
Schedule/Travel:
- Non-standard schedule may be required (weekends/2nd shift/night shift/calls). Minimal travel.
Work Location: On Premise
Last Date To Apply: August 14, 2026
Compensation/Benefits: Base salary $82,700–$137,900; bonus target 10%. Benefits include 401(k) with Pfizer matching, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health coverage.