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DescripciónDescription
Provide support to CORPORATE STERILIZATION WORKSTREAM for efficient and timely completion of project related to sterilization area including, new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others. Interprets microbiological testing data, monitors, and maintains the sterility assurance. SENIOR LEVEL professional/team player with advanced knowledge and experience. Relevant experience and sufficient knowledge and experience to serve as a subject matter expert in one or more of the following areas: Ethylene oxide sterilization validation and requalification, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, Reusable Medical Devices, Radiation sterilization validation and dose audit management, Controlled environment monitoring.
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Requisitos Requirements
Bachelor’s degree in microbiology or similar discipline. Minimum of 7 years of experience in regulated environments with knowledge in sterilization processes. Experience conducting microbial test method validations and managing projects independently. Experience with controlled environment monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management. Working knowledge of applicable regulations and their interpretation within industry. Ability to track and manage projects. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Project Management and Microsoft Project skills. Fully bilingual (English and Spanish) SUBJECT MATTER EXPERTS ARE ENCOURAGED TO APPLY.
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