Senior Validation Engineer

Pfizer • Rochester, MI

2d

About The Position

The Senior Validation Engineer supports product quality and patient safety by ensuring validation activities comply with company standards, Pfizer Quality Standards, and regulatory requirements. The role reviews and approves validation master plans, protocols, reports, and related technical documents; troubleshoots validation issues; and provides statistical and high-level data analysis support for testing results, process anomalies, and Quality Investigations.

The position contributes to moderately complex projects, manages routine Quality systems, coordinates testing with functional groups, and maintains the Site Validation Master Plan. It also supports regulatory audits, product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation. The engineer integrates validation schedules into production and participates in deviation investigations. The role is based at a Penicillin facility, and the candidate must not be allergic to penicillin.

Requirements

• High school diploma or equivalent and 8+ years of experience; or associate’s degree and 6+ years of experience; or BA/BS and 2+ years of experience; or MBA/MS with any years of relevant experience.
• Proven expertise in Good Manufacturing Practices.
• Strong working knowledge of quality systems and processes.
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.
• Excellent verbal and written communication skills.
• Ability to work independently and in a team environment.
• Must not be allergic to penicillin because this is a Penicillin Facility.

Nice To Haves

• Strong technical knowledge of validation or qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
• Experience with sterile products and medical devices.
• Strong analytical and problem-solving skills.
• Strong organizational and time management skills.
• Ability to mentor and guide colleagues.
• Experience in regulatory audits and compliance.
• Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and enhance productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports for compliance with company standards and regulatory requirements.
• Troubleshoot validation issues involving equipment and performance processes and provide expertise to resolve them.
• Conduct statistical analysis of testing results and process anomalies, and provide high-level data analysis support for Quality Investigations.
• Guide the writing, review, and approval of validation process documents and technical reports in accordance with current Pfizer Quality Standards.
• Contribute to moderately complex projects, manage time effectively, and plan short-term work activities.
• Manage routine Quality systems, including Change Control, Quality Agreement, Documentation, and Investigations.
• Coordinate testing with functional groups.
• Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
• Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation.
• Integrate validation schedules into production and participate in deviation investigations.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Participation in Pfizer’s Global Performance Plan, with a bonus target of 10.0% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED