Also referred to as:
Quality Assurance Analyst I - Sterilization, Quality Engineer I - Sterilization, Validation Engineer I - Sterilization
Requirements and Responsibilities
Sterilization Engineer I 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 I 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 I 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 I work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Sterilization Engineer I typically requires 0-2 years of related experience.
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