Senior Validation Engineer

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.

• 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.

• 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.

• 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.