Senior Validation Engineer

Pfizer; Rochester (MI); On-site; USD 83,000 - 138,000; Full time

Job summary

Pfizer in the United States (Michigan, Rochester) is seeking a Senior Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer quality standards.

You will troubleshoot validation issues, conduct statistical analyses, guide document writing, manage Change Control and Investigations, and support regulatory audits and product transfers. The role requires strong GMP knowledge and collaboration across teams.

Qualifications

• Minimum requirements include 8+ years with HSD, 6+ years with an Associate’s, or 2+ years with a BA/BS; advanced degrees optional.
• Proven GMP expertise and familiarity with QA systems and regulatory expectations.
• Strong written/verbal communication and ability to work independently or in teams.
• Experience with regulatory audits and compliant documentation practices.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports to ensure regulatory compliance.
• Troubleshoot validation issues for equipment and processes and provide data-driven resolutions.
• Conduct statistical analysis of testing results and support Quality Investigations.
• Guide writing, review, and approval of validation documents and technical reports.
• Manage Quality systems like Change Control and Investigations; coordinate testing with groups.
• Support regulatory audits, product transfers, and regulatory queries; participate in deviation investigations.

Skills

GMP Expertise

Quality Systems Knowledge

Analytical Skills

Communication Skills

Teamwork

Regulatory Compliance

Education

High school diploma or equivalent

Associate’s degree

BA/BS in related field

MBA/MS with any years

Tools

Global Document Management System

SAP / System Applications & Products

Quality Tracking System

Job description

Senior Validation Engineer### Senior Validation Engineer申请: United States - Michigan - Rochester: 全职: 今天发布: 4965652**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**Physical/Mental Requirements:*** This is a Penicilin Facility, candidate must NOT be allergic to Penicillin **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 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 **Other Job Details:*** Working hours: 7 am - 3:30 pm* Last day to apply: November 4th, 2026. 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.**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.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.