Senior Validation Engineer

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

Benefits offered by this job

401(k) with Pfizer matching

Pfizer Retirement Savings Contribution

Paid vacation, holidays, personal days

Health benefits

Relocation assistance (where eligible)

Job summary

Pfizer in Rochester seeks a Senior Validation Engineer to plan and lead validation activities for manufacturing processes, equipment and systems. You will develop lifecycle documents and work with area owners and suppliers to ensure compliance with company policies and regulatory guidelines.

The role requires GMP experience, strong problem-solving, and the ability to support audits and regulatory inspections while collaborating across departments.

Qualifications

• 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.
• Experience with GMPs and regulatory expectations.
• Strong written and verbal communication and ability to work cross-functionally.

Responsibilities

• Plan, schedule, execute and lead validation projects for manufacturing processes, equipment and systems.
• Develop protocols, test scripts and reports through lifecycle from initiation to monitoring.
• Support audit preparations and regulatory inspections as required.
• Perform risk assessments and investigate deviations related to validation.
• Lead project teams and coordinate with area owners and suppliers.

Skills

Good Manufacturing Practices

Quality systems knowledge

Verbal and written communication

Independent and team work

Education

BA/BS with 2+ years of relevant experience

Associate’s degree with 6+ years of experience

MBA/MS with any years of relevant experience

Tools

Global Document Management System

SAP (Systems, Applications & Products)

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

The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring. The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are adhered to. This role will assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.

How You Will Achieve It

• Support the validation/qualification of manufacturing equipment, facility, combination product and critical utility systems.
• Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles
• Support the validation/qualification of laboratory equipment
• Develop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents
• Develop/Author validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification
• Work cross functionally with multiple departments to schedule and complete all required activities
• Support corrective actions including investigating and resolving deviations as relevant to validation
• Support technical training on process and technology as required by the project
• Support audit preparation and defend areas of Validation responsibility
• Carryout process capability analysis on all commercial processes on a periodic basis. Identify areas for improvement where process capability is deemed to be unacceptable
• Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
• Review site change controls to ensure the validated state of a process is not impacted by a proposed change
• Lead the implementation of projects to reduce process risk, optimize plant and process productivity
• Will required qualification in Aseptic Gouning and Techniques for cleanroom environments (Grade A through Grade D) Role will require after hour and weekend support from time to time

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

• Must be able to lift a minimum of 30lbs The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must not have Penicillin allergy. Minimal travel for training/seminars. Work Location Assignment: On Premise

Last Date To Apply: October 1, 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 your candidate AI-use guidelines available at Pfizer Careers.

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.