Senior Validation Engineer for GMP Sterile Processes

Pfizer; Rochester (MI); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Pfizer Retirement Savings Contribution

Paid vacation, holidays, personal days

Health benefits

Relocation assistance (where eligible)

Job summary

Pfizer in Rochester seeks a Senior Validation Engineer to plan and lead validation activities for manufacturing processes, equipment and systems. You will develop lifecycle documents and work with area owners and suppliers to ensure compliance with company policies and regulatory guidelines.

The role requires GMP experience, strong problem-solving, and the ability to support audits and regulatory inspections while collaborating across departments.

Qualifications

• 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.
• Experience with GMPs and regulatory expectations.
• Strong written and verbal communication and ability to work cross-functionally.

Responsibilities

• Plan, schedule, execute and lead validation projects for manufacturing processes, equipment and systems.
• Develop protocols, test scripts and reports through lifecycle from initiation to monitoring.
• Support audit preparations and regulatory inspections as required.
• Perform risk assessments and investigate deviations related to validation.
• Lead project teams and coordinate with area owners and suppliers.

Skills

Good Manufacturing Practices

Quality systems knowledge

Verbal and written communication

Independent and team work

Education

BA/BS with 2+ years of relevant experience

Associate’s degree with 6+ years of experience

MBA/MS with any years of relevant experience

Tools

Global Document Management System

SAP (Systems, Applications & Products)

Quality Tracking System

Job description

Pfizer in Rochester seeks a Senior Validation Engineer to plan and lead validation activities for manufacturing processes, equipment and systems. You will develop lifecycle documents and work with area owners and suppliers to ensure compliance with company policies and regulatory guidelines.

The role requires GMP experience, strong problem-solving, and the ability to support audits and regulatory inspections while collaborating across departments.