Senior Validation Engineer: Lead GMP Validation Projects

AI Chopping Block, Inc.; Rochester, Northern (MI, KY); Hybrid; USD 83,000 - 138,000; Full time

Job summary

Pfizer is seeking a Rochester-based Senior Validation Engineer to lead comprehensive validation programs for manufacturing processes and equipment. You will develop master plans and lifecycle documents, coordinate with cross-functional teams, and ensure compliance across regulatory standards.

Responsibilities include coordinating qualification activities (DQ/IQ/OQ/PQ), supporting audits, and guiding process improvements.

Qualifications

• High level of GMP experience and quality systems knowledge.
• Strong written and verbal communication abilities.
• Ability to work independently and in a team environment.

Responsibilities

• Plan, schedule, execute and lead validation/qualification projects.
• Develop validation master plans, protocols, and reports across lifecycle phases.
• Collaborate with area owners and suppliers to finalize requirements.
• Support regulatory inspections and risk assessments.

Skills

GMP knowledge

Quality systems

Communication skills

Teamwork

Education

High school diploma or equivalent

Associate’s degree

BA/BS degree

Tools

GDM System

SAP

Quality Tracking System

Job description

Pfizer is seeking a Rochester-based Senior Validation Engineer to lead comprehensive validation programs for manufacturing processes and equipment. You will develop master plans and lifecycle documents, coordinate with cross-functional teams, and ensure compliance across regulatory standards.

Responsibilities include coordinating qualification activities (DQ/IQ/OQ/PQ), supporting audits, and guiding process improvements.