Principal Validation Engineer

Pfizer; Andover (MA); On-site; USD 120,000 - 202,000; Full time

Job summary

A leading company in biopharmaceuticals seeks a Principal Validation Engineer at their Andover site. In this key role, you will own site validation processes, collaborate on complex projects, and ensure compliance standards are met. This position offers the opportunity to influence significant outcomes in a fast-paced environment.

Benefits

401(k) plan with Pfizer Matching Contributions

Paid vacation and personal days

Health benefits including medical, dental, and vision coverage

Relocation assistance may be available

Qualifications

• 6+ years experience with BA/BS or 5+ years with MBA/MS.
• Project management and leading complex projects experience.
• Ability to influence and collaborate in a team environment.

Responsibilities

• Principal owner of overall site validation philosophy and master plan.
• Lead site validation planning for large capital projects.
• Manage the effectiveness and compliance of validation programs.

Skills

Effective written and verbal communication

Strong interpersonal skills

Project management

Problem-solving

Leadership

Analytical thinking

Education

BA/BS, MBA/MS, PhD/JD, MD/DVM

Job description

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

The annual base salary for this position ranges from $120,800.00 to $201,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Engineering