Senior Validation Engineer

Rochester Senior Validation EngineerThe 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.What You Will AchieveIn this role, you will: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) cyclesSupport the validation/qualification of laboratory equipmentDevelop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documentsDevelop/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 requalificationWork cross functionally with multiple departments to schedule and complete all required activitiesSupport corrective actions including investigating and resolving deviations as relevant to validationSupport technical training on process and technology as required by the projectSupport audit preparation and defend areas of Validation responsibilityCarry out process capability analysis on all commercial processes on a periodic basis. Identify areas for improvement where process capability is deemed to be unacceptableSupport 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 changeLead the implementation of projects to reduce process risk, optimize plant and process productivityWill required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D)Here Is What You Need (Basic Requirements)Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.Bonus Points If You Have (Preferred Requirements)Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systemsExperience with sterile products and medical devicesStrong analytical and problem-solving skillsStrong organizational and time management skillsAbility to mentor and guide other colleaguesExperience in regulatory audits and complianceExperience 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 usePHYSICAL/MENTAL REQUIREMENTSThis is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin.Must be able to aseptically gown.Able to lift 25-30 lbs.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSNon-standard work schedule at times may be required to support product release, including weekend, second shift, night shift work / call for process decisions.Minimal travel for training/seminars.Relocation support available Work Location Assignment: On PremiseLast Date To Apply: August 3rd, 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.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 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 View email address on click.appcast.io. 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.