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.
