Sterilization Validation - CQV Engineer

*Position Summary* The Sterilization Validation/CQV Engineer will support development and execution of sterilization qualification activities involving autoclaves, SIP systems, thermometric studies, Biological Indicators, and associated sterilization cycles. *Key Responsibilities* * Develop and execute Sterilization PQ protocols. * Prepare the corresponding Sterilization PQ final reports. * Review existing and new autoclave cycles and load configurations. * Support the qualification of new or modified sterilization cycles. * Coordinate thermometric studies, including thermocouple and Biological Indicator placement and retrieval. * Review temperature profiles, exposure times, lethality calculations, and other applicable cycle parameters. * Evaluate sterilization cycle results against approved protocol acceptance criteria. * Support sterilization conditional release activities as required. * Review SIP cycles, when applicable. * Generate and review PI Historian trends. * Identify and communicate any nonconforming or unexpected sterilization results. * Support investigations and technical assessments related to execution issues or discrepancies. * Coordinate execution activities with Manufacturing, Engineering, QC/Microbiology, and Quality. * Provide execution support during off-shifts, weekends, and extended-hour activities based on project needs. * Review sterilization calculations, data, and execution results as required. *Minimum Recommended Qualifications* * Bachelor's degree in Engineering, Microbiology, Biotechnology, Life Sciences, or a related field. * At least 5 years of experience in validation within the pharmaceutical or biotechnology industry. * At least 3 years of experience supporting sterilization validation activities. * Hands-on experience with autoclave qualification. * Experience with thermometric studies and the use of Biological Indicators. * Knowledge of SIP systems and sterilization cycle parameters. \*Weil Group is proud to be an Equal Employment Opportunity Employer.\* #IND2 Education: * Bachelor's (Required) Experience: * validation: 5 years (Required) * Sterilization Validation: 5 years (Preferred) Work Location: In person