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The Project Validation Specialist will be responsible for provide support to Corporate / Division Sterilization Workstream to ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements
Requisitos - Requirements
Bachelor's Degree in Engineering, Microbiology or similar discipline.
Minimum of 5-7 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes..
Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
Experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
Experience in 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
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Able t
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