Also referred to as:
Quality Assurance Analyst II - Sterilization, Quality Engineer II - Sterilization, Validation Engineer II - Sterilization
Requirements and Responsibilities
Sterilization Engineer II develops and supports sterilization processes to ensure manufactured products meet quality, safety, and regulatory requirements. Designs, validates, and maintains sterilization processes using methods such as steam, ethylene oxide, hydrogen peroxide, or radiation. Being a Sterilization Engineer II performs process validation activities including IQ, OQ, and PQ in accordance with regulatory and quality standards. Analyzes sterilization data and investigates process deviations, nonconformances, and corrective actions. Additionally, Sterilization Engineer II collaborates with manufacturing, quality, and product development teams to support new product introductions and process changes. Maintains technical documentation, protocols, and reports to ensure compliance with internal procedures and external regulations. Requires a bachelor's degree. Typically reports to a manager. The Sterilization Engineer II occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Sterilization Engineer II typically requires 2-4 years of related experience.
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