What You Will AchieveThe 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 Gowning 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 REQUIREMENTSMust 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 PremiseLast Date To Apply: October 1, 2026The 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 ActPfizer 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.
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.
Quality Assurance and Control
