Senior Validation Engineer – Pharma Process Validation

Pfizer; Michigan; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Pfizer Rochester in Michigan is seeking a Senior Validation Engineer to lead the planning, execution, and qualification of manufacturing processes, equipment, and utilities. You will author essential plans and reports and collaborate across departments to ensure compliance with regulations and internal standards.

The role requires a bachelor’s degree with 2+ years of experience, or a master’s with 0+ years, and offers relocation support.

Qualifications

• Bachelor's degree or higher with relevant validation experience in manufacturing.
• Experience planning, executing and leading qualification/validation life cycles.
• Ability to develop/author plans, protocols, and reports across OQ, IQ, PQ and related documents.

Responsibilities

• Plan, schedule, and lead validation projects for manufacturing processes, equipment, utilities, and sterilization.
• Develop validation master plans, SOPs, and risk assessments.
• Collaborate with area owners and suppliers to finalize qualification requirements.
• Support regulatory inspections and assist in deviations investigations.
• Lead process capability analyses and support annual product quality reporting.

Skills

Validation expertise

Quality systems

Analytical thinking

Project planning

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Master's degree (advantageous)

Tools

Microsoft Office

GxP computer systems

Job description

Pfizer Rochester in Michigan is seeking a Senior Validation Engineer to lead the planning, execution, and qualification of manufacturing processes, equipment, and utilities. You will author essential plans and reports and collaborate across departments to ensure compliance with regulations and internal standards.

The role requires a bachelor’s degree with 2+ years of experience, or a master’s with 0+ years, and offers relocation support.