Pfizer

Senior Validation Engineer

United States - Michigan - Rochester · Senior

Sponsorship not specified$25k-$30kDetected 1 day ago

AccessibilityRecruitingMedical DevicesProblem SolvingTime Management

About the role

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 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.

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 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
Support corrective actions including investigating and resolving deviations as relevant to validation
Support audit preparation and defend areas of Validation responsibility
Lead the implementation of projects to reduce process risk, optimize plant and process productivity
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Must be able to aseptically gown.
Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.
This role will assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.
Work cross functionally with multiple departments to schedule and complete all required activities
Support technical training on process and technology as required by the project
Will required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D)
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.

Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
The annual base salary for this position ranges from $82,700.00 to $137,900.00.

Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com).
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.
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.
Pfizer compensation structures and benefit packages are aligned based on the location of hire.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

This listing is sourced directly from Pfizer's careers page and normalized into a canonical job model.