Principal Validation Engineer
PfizerAbout the role
Use Your Power for Purpose
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.
What You Will Achieve
In this role, you will:
Principal owner of overall Andover site validation philosophy and master plan in partnership with local owners of validation programs, associated technical disciplines, 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
Site Validation 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
The Principal Validation Engineer is a member of the Andover STS leadership team.
Here Is What You Need (Minimum Requirements)
BA/BS 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
Effective written and verbal communication skills
Strong interpersonal skills and the ability to work collaboratively in a team environment across various business functions
Experience in project management and leading complex projects
Ability to develop and manage plans to achieve objectives
Bonus Points If You Have (Preferred Requirements)
Experience in problem-solving, negotiations, presentation, and supervision of a multi-layered organization
Understanding of DAMIC (six sigma) tools and practices with a focus on continuous improvement
Experience developing philosophies/approaches for or managing validation programs applicable to the manufacture of biopharmaceutical drug substance, drug product, or medical device
Experience or broad knowledge in biopharmaceutical development, manufacturing, and lifecycle management
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
Excellent analytical and strategic thinking abilities
Ability to influence and drive alignment across stakeholders
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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
Schedule is 1st shift, Monday - Friday.
Occasional domestic and international travels
Occasional off-hour support to address time-sensitive production and business-related issues
Work Location Assignment: Hybrid
OTHER JOB DETAILS
- Last Date to Apply for Job: June 12, 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
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