Senior Validation Engineer

Pfizer • Rochester, MI

17h • $82,700 - $137,900

About The Position

The Senior Validation Engineer supports quality and regulatory compliance by evaluating and approving validation plans, protocols, and reports; troubleshooting validation issues; and providing statistical and data-analysis expertise for testing, process anomalies, and Quality Investigations. The role guides the creation and review of validation documents and technical reports in accordance with current Pfizer Quality Standards.

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 initiatives, and Cleaning Validation. The engineer integrates validation schedules with production and participates in deviation investigations. The facility is a penicillin facility; candidates must not be allergic to penicillin. Working hours are 7:00 a.m. to 3:30 p.m.

Requirements

• High school diploma or equivalent with 8 or more years of experience; or associate’s degree with 6 or more years of experience; or BA/BS with 2 or more 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, as 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 productivity, with curiosity about improving outcomes and understanding responsible AI practices, 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 for 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 and support regulatory audits.
• 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, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Possible relocation assistance based on business needs and/or eligibility.
• Eligible 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