Pfizer

Senior Validation Engineer

In short

Senior Validation Engineer role at Pfizer's Rochester, Michigan manufacturing site (a Penicillin facility, so candidates must not be allergic to Penicillin), focused on evaluating and approving validation master plans, protocols, and reports, troubleshooting validation issues, and managing quality systems like Change Control and Documentation. Requires GMP expertise, a BA/BS with 2+ years of experience (or equivalent combinations), and strong knowledge of quality systems; preferred experience includes sterile products, medical devices, and regulatory audits. Onsite role with annual base salary $82,700–$137,900 plus a 10% bonus target; no visa sponsorship is offered.

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:
•Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
•Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
•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, ensuring adherence to the latest Pfizer Quality Standards.
•Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
•Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and 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, ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
•High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
•Proven expertise in Good Manufacturing Practices
•Strong working knowledge of various 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
Physical/Mental Requirements:
•This is a Penicillin Facility, candidate must NOT be allergic to Penicillin
Bonus Points If You Have (Preferred Requirements)
•Strong technical knowledge with validation/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 other 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. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Other Job Details
•Working hours: 7 am - 3:30 pm
•Last day to apply: November 4th, 2026.
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
This position requires permanent work authorization in the United States.

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