Description
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.
You will deliver overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network.
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 policies, 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 utilised 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.
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.
Preferred Requirements
- 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 organisation 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 organisation.
Physical/Mental Requirements
- Ability to perform mathematical calculations, scientific computation, complex data analysis, verbal communication, written communication.
Non-Standard Work Schedule, Travel or Environment Requirements
- Occasional domestic and international travels.
- Occasional off-hour support to address time-sensitive production and business-related issues.
Benefits
- Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support each of life's moments.
- 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.
- Health benefits including medical, prescription drug, dental and vision coverage.