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Senior Staff Sterilization Engineer Location: US-FL-Weston Email this job to a friend
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Responsibilities: - Strong understanding of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat. Act as SME in the sterilization technique
- Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
- Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
- Support product transfers to other plants/facilities.
- Review/approve nonconforming material and system documentation.
- Review/approve product and process change control documentation and specifications.
Requirements: - Bachelor's Degree in Microbiology, Biology, Engineering or a closely related life science.
- 6 + years of medical device, pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
- Experience with steam sterilization, preferred
- Knowledge or experience with ETO and/or gamma radiation
- Experience in reprocessing of re-useable medical device instruments and the cleaning validations associated with the devices highly preferred
- Medical device industry experience
- Sterilization certificate and/or training (ETO, Gamma, Steam, Gas Plasma, etc.)
- Excellent written and verbal communication skills
Katalyst HealthCares & Life Sciences Inc
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