Senior Validation Engineer

Pfizer; Rochester, Northern (MI, KY); Hybrid; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with company matching

Comprehensive health benefits

Job summary

Pfizer in the United States is seeking an experienced Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer Quality Standards.

You will troubleshoot validation issues, perform statistical analyses of testing results, and support regulatory audits while coordinating with cross-functional teams to maintain the Site Validation Master Plan and drive timely product releases.

Qualifications

• High school diploma (or equivalent) with 8+ years' experience, or associate’s degree with 6+ years, or BA/BS with 2+ years, or MBA/MS with any years of relevant experience.
• Proven expertise in Good Manufacturing Practices.
• Familiarity with information systems such as Global Document Management System, SAP, and Quality Tracking System.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer Quality Standards.
• Troubleshoot validation issues for equipment and processes, offering resolution expertise.
• Conduct statistical analysis of testing results and process anomalies; provide data analysis support for quality investigations.
• Guide writing, review, and approval of validation process documents and technical reports.
• Maintain Site Validation Master Plan; support regulatory audits; coordinate testing with functional groups.

Skills

Good Manufacturing Practices

Quality systems

Information systems familiarity

Education

High school diploma

Associate’s degree

BA/BS degree

MBA/MS degree

Tools

Global Document Management System

SAP

Quality Tracking System

Job description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.

What You Will Achieve

In this role, you will: Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution. Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations. Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards. Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities. Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups. Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams. Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Proven expertise in Good Manufacturing Practices
• Strong working knowledge of various quality systems and processes
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
• Excellent verbal and written communication skills
• Ability to work independently and in a team environment

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with sterile products and medical devices
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other colleagues
• Experience in regulatory audits and compliance
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

This is a penicillin manufacturing facility. All candidates applying mist NOT be allergic to penicillin. Must be able to aseptically gown. Able to lift 25-30 lbs

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions. Minimal travel for training/seminars.

Work Location Assignment:

On Premise

Last Date To Apply:

September 15, 2026

Salary and Benefits

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

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.

Quality Assurance and Control

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.