Senior Validation Engineer - Pharma Quality & Compliance

Pfizer; Rochester, Northern (MI, KY); Hybrid; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) matching

Paid vacation

Comprehensive health benefits

Dental and vision

Parental and medical leave

Job summary

Pfizer is seeking a Senior Validation Engineer for its Rochester, Michigan site. The role focuses on evaluating and approving validation master plans, protocols, and reports to ensure compliance with Pfizer quality standards and regulatory requirements.

You will troubleshoot validation issues, analyze data, and support quality investigations. You will also guide documentation, maintain the Site Validation Master Plan, assist with regulatory audits, and participate in product transfers and

Qualifications

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years or BA/BS with 2+ years or MBA/MS with any years of relevant experience
• Proven expertise in Good Manufacturing Practices
• Familiarity with information systems such as Global Document Management System, SAP, and Quality Tracking System
• Excellent verbal and written communication skills
• Ability to work independently and in a team environment

Responsibilities

• 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
• 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

Skills

Validation expertise

GMP

Statistical analysis

Documentation

Education

Bachelor's degree

MBA/MS in relevant field

Tools

Global Document Management System

SAP

Quality Tracking System

Job description

Pfizer is seeking a Senior Validation Engineer for its Rochester, Michigan site. The role focuses on evaluating and approving validation master plans, protocols, and reports to ensure compliance with Pfizer quality standards and regulatory requirements.

You will troubleshoot validation issues, analyze data, and support quality investigations. You will also guide documentation, maintain the Site Validation Master Plan, assist with regulatory audits, and participate in product transfers and