Principal Validation Engineer

Pfizer • Andover, MA

1d • $124,400 - $207,400 • Hybrid

About The Position

The Principal Validation Engineer under Andover Site Technical Services (STS) is the principal owner of the Pfizer (PGS) Andover site validation program and master plan. The incumbent is responsible for delivering overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network.

Requirements

• BA/BS degree in Science or Engineering with 6+ years of experience or MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experience
• Experience in 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
• Ability to perform mathematical calculations, scientific computation, complex data analysis, verbal communication, written communication

Nice To Haves

• Experience developing philosophies/approaches for or managing validation programs applicable to the manufacture of biopharmaceutical drug substance, drug product, or medical device
• Active participation in industrial/professional organization focused on advancing biopharmaceutical development, manufacturing, 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 overall Andover site validation philosophy and master plan in partnership with local validation program owners, technical subject matter experts, and relevant Pfizer global/network/site quality system principals applicable to biologics drug substance/drug substance intermediate production, testing, storage, and transport
• Operate PMO for Validation Program Lifecycle Projects
• Establish and maintain site governances necessary to interpret validation philosophies and polices, implement and improve uniform validation practices and approaches, as well as to measure and maintain site validation program health
• Maintain STS departmental infrastructure, and provide planning support for third party services utilized in validation and other technical services; oversee third party service provider service level and quality of service
• Program owner and expert for select technical/validation disciplines
• 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
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility

What This Job Offers

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