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Senior Validation Engineer

Job in Rochester, Oakland County, Michigan, 48308, USA
Listing for: Pfizer, S.A. de C.V
Seasonal/Temporary position
Listed on 2026-03-01
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 82700 USD Yearly USD 82700.00 YEAR
Job Description & How to Apply Below

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

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)
  • Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 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.
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 ChatGPT or 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.
Physical/Mental Requirements

• This is a Penicilin Facility; candidate must NOT be allergic to Penicillin.

• Must be able to lift a minimum of 30 lbs.

• The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

Salary & Benefits

The annual base salary for this position ranges from $82,700.00 to $. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan…

Position Requirements
10+ Years work experience
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