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Senior Validation Engineer

Pfizer

United States - Michigan - RochesterSenior$82.7k – $137.9k/yrH-1B sponsor company
Sign in to applyVerified 2h ago
Location
United States - Michigan - Rochester
Work model
On-Site
Level
Senior
Salary
$82.7k – $137.9k/yr
H-1B history
9 approvals (FY2023)
Posted
6h ago

About this role

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 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 penicillin manufacturing facility.  All candidates applying mist NOT be allergic to penicillin. Must be able to aseptically gown. Able to lift 25-30 lbs NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions. Minimal travel for training/seminars. Work Location Assignment: On Premise Last Date To Apply: August 14, 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

Senior Validation Engineer at Pfizer, United States - Michigan - Rochester | Yoinka