Senior Validation Engineer

Job Overview

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. The role also includes developing and authoring project plans, protocols, test scripts and reports throughout the entire life cycle, working closely with area owners and suppliers to finalize validation/qualification requirements, troubleshooting, performing gap and risk assessments, supporting regulatory inspections, and conducting training as required.

• Support the validation/qualification of manufacturing equipment, facility, and critical utility systems.
• Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles.
• Support validation/qualification of laboratory equipment.
• Develop, author, and execute FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other validation life‑cycle documents.
• Develop validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols for 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 by investigating and resolving deviations relevant to validation.
• Provide technical training on process and technology as required by the project.
• Assist in audit preparation and defend areas of Validation responsibility.
• Carry out process capability analysis on all commercial processes periodically; identify areas for improvement where performance is unacceptable.
• Support preparation and review of 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 proposed changes.
• Lead the implementation of projects to reduce process risk and optimize plant and process productivity.
• Attain required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D).

• Bachelor's degree with at least 2 years of experience; OR master's degree with 0+ years of experience; OR associate’s degree with 6 years of experience; OR high school diploma (or equivalent) with 8 years of relevant experience.

• Strong technical knowledge of 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 responsible AI practices including risk management and ethical use.

• The facility manufactures penicillin; all candidates must not be allergic to penicillin.
• Must be able to aseptically gown.
• Able 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 process decisions.
• Minimal travel for training and seminars.

Annual base salary range: $82,700.00 – $. Eligible for Pfizer’s Global Performance Plan with a bonus target of 10.0% of base salary. Comprehensive benefits include 401(k) with matching contributions, Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, and vision coverage). Phoenix compensation structures and benefit packages are aligned based on location of hire.

Relocation assistance may be available based on business needs and/or…