Principal Validation Engineer

Pfizer • Andover, MA

23h • $124,400 - $207,400 • Hybrid

About The Position

The Principal Validation Engineer in Andover Site Technical Services (STS) is the principal owner of the Pfizer Global Supply (PGS) Andover site validation program and master plan. The role delivers overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network.

The position establishes and maintains the site validation philosophy and master plan, operates the project management office for validation program lifecycle projects, and develops site governance to implement consistent validation practices and monitor program health. It also maintains STS departmental infrastructure, supports planning and oversight of third-party services, serves as program owner and expert for selected technical and validation disciplines, contributes to capital project portfolio and expense planning, and leads validation planning for large capital or complex asset lifecycle projects.

Requirements

• BA/BS degree in Science or Engineering with 6 or more years of experience; or MBA/MS with 5 or more years of experience; or PhD/JD with 1 or more year of experience; or MD/DVM with any years of relevant experience.
• Experience in the pharmaceutical, biopharmaceutical, or biotechnology industry.
• Experience or broad knowledge in biopharmaceutical development, manufacturing, and lifecycle management.
• Experience in project management and leading complex projects.
• Effective written and verbal communication skills.
• Strong interpersonal skills and the ability to work collaboratively in a team environment across various business functions.

Nice To Haves

• Experience developing philosophies or approaches for, or managing, validation programs applicable to manufacturing biopharmaceutical drug substance, drug product, or medical devices.
• Active participation in an industrial or professional organization focused on advancing biopharmaceutical development, manufacturing, or regulatory practices.
• Demonstrated ability to lead or build teams for complex technical projects involving risk management.
• Demonstrated leadership in a matrix organization.

Responsibilities

• Establish and maintain the Andover site validation philosophy and master plan in partnership with local validation program owners, technical subject matter experts, and relevant Pfizer global, network, site, and quality-system principals.
• Apply the site validation philosophy and master plan to biologics drug substance and drug substance intermediate production, testing, storage, and transport.
• Operate the project management office for validation program lifecycle projects.
• Establish and maintain site governance to interpret validation philosophies and policies, implement and improve uniform validation practices and approaches, and measure and maintain site validation program health.
• Maintain STS departmental infrastructure and provide planning support for third-party services used in validation and other technical services.
• Oversee third-party service-provider service levels and quality of service.
• Serve as program owner and expert for selected technical and validation disciplines.
• Support STS capital project portfolio and expense planning.
• Lead site validation planning and management of validation activities for large capital or complex asset lifecycle projects.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 17.5% of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal