Senior Validation Engineer

Overview

The Rochester Senior Validation Engineer leads planning, scheduling, executing and guiding validation projects related to manufacturing processes, equipment, critical utilities, product, cleaning and sterilization. This role develops and authorizes project plans, protocols, test scripts and reports across the full lifecycle from initiation to ongoing monitoring. Collaboration with area owners and suppliers ensures validation/qualification requirements align with company policies, procedures and regulatory guidelines.

The position may include troubleshooting, gap and risk assessments, regulatory inspection support and required training.

• Support validation/qualification of manufacturing equipment, facilities and critical utility systems.
• Validate product, cleaning, shipping, aseptic processing (media fill) and sterilization (steam) cycles.
• Validate laboratory equipment.
• Develop and execute validation life-cycle documents (FRS, URS, FATs, SATs, DQ, IQ, OQ, PQ) and other relevant materials.
• Develop/author validation master plans, SOPs, programs and policies; conduct system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification.
• Coordinate cross-functionally with multiple departments to schedule and complete activities.
• Support corrective actions, investigations and deviations as they relate to validation.
• Provide technical training on processes and technologies as required by projects.
• Assist in audit preparation and defend areas of Validation responsibility.
• Carry out process capability analysis on commercial processes periodically and identify improvement opportunities where capability is unacceptable.
• Prepare and review sections of the Annual Product Quality Reports (APQR).
• Review site change controls to ensure validated state is not impacted by proposed changes.
• Lead projects to reduce process risk and optimize plant and process productivity.
• Where applicable, complete qualification in aseptic gowning and cleanroom techniques (Grade A through
  
  D).

• Bachelor’s degree with at least 2 years of experience; or a Master’s degree with 0+ years; or an Associate’s degree with 6 years; or a high school diploma (or equivalent) with 8 years of relevant experience.

• Strong technical knowledge in validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
• Experience with sterile products and medical devices.
• Strong analytical, problem-solving, organizational and time management skills.
• Ability to mentor and guide colleagues.
• Experience in regulatory audits and compliance.
• Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) to support problem solving; demonstrated curiosity in responsible AI practices including risk management and ethical use.

This is a penicillin manufacturing facility; candidates must not be allergic to penicillin and must be able to aseptically gown. Ability to lift 25–30 lbs.

Non-standard work schedule may be required to support product release, including weekends, second shift, night shift, or on-call decisions. Minimal travel for training/seminars. Relocation assistance may be available.

Work Location:

On Premise. Salary range: $82,700.00 to $. Eligible for Pfizer Global Performance Plan with a target bonus of 10% of base salary. Benefits include 401(k) with company matching, retirement contributions, paid time off, caregiver/parental and medical leave, and comprehensive health benefits. Hiring is subject to location and eligibility requirements.

Pfizer is an equal opportunity employer. We comply with applicable nondiscrimination laws and work authorization requirements. This posting complies with accessibility standards and provides accommodation on request via dis Information on AI usage guidelines for recruitment is available on Pfizer Careers.