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.*