Principal Validation Engineer
Core
Principal owner of the Pfizer Andover site validation program and master plan, ensuring compliance and effectiveness for biologics drug substance/drug product production, testing, storage, and transport.
Role type
Principal Validation Engineer (Site Program Owner)
Builds
Site validation program effectiveness, governance frameworks, and lifecycle management for large capital/complex asset projects.
Domain
Biopharmaceutical manufacturing and quality assurance
Required skills
Validation program management, project management, biopharmaceutical lifecycle management, third-party service oversight, capital project planning, risk management
Preferred skills
Validation philosophy development, industrial organization participation, team building in matrix organizations
Technologies
None explicitly listed
Responsibilities
Establish and maintain site validation philosophy and master plan, operate PMO for validation lifecycle projects, maintain site governance, oversee third-party service providers, lead validation planning for complex asset projects
Seniority
Principal, strategy & mentorship