Senior Validation Engineer

Pfizer • Rochester, MI

7d

About The Position

The Senior Validation Engineer supports quality and compliance for pharmaceutical products by evaluating, reviewing, and approving validation plans, protocols, and reports. The role troubleshoots validation issues, analyzes testing results and process anomalies, and provides data-analysis support for Quality Investigations. It guides validation documentation and technical reports in accordance with Pfizer Quality Standards and manages routine Quality systems, including Change Control, Quality Agreements, Documentation, and Investigations.

The position maintains the Site Validation Master Plan, supports regulatory audits, and represents engineering validation on site or network teams. It also supports product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation; integrates validation schedules into production; coordinates testing with functional groups; and participates in deviation investigations. The role contributes to moderately complex projects and plans short-term work activities.

This is a Penicillin facility, and candidates must not be allergic to Penicillin. The stated working hours are 7:00 a.m. to 3:30 p.m. The position requires permanent U.S. work authorization; visa sponsorship is unavailable. Relocation assistance may be available based on business needs and/or eligibility.

Requirements

• One of the following education and experience combinations: high school diploma or equivalent and 8+ years of experience; associate’s degree and 6+ years of experience; BA/BS and 2+ years of experience; or MBA/MS and 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.

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 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 Agreements, 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.
• Potential relocation assistance based on business needs and/or eligibility.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 10.0% of base salary.

What This Job Offers

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