Sterilization Associate
Synkriom
Job Description
Job Description
JOB DESCRITION:
Sterility Assurance Engineer
We are seeking a Sterility Assurance Engineer to support the development, validation, and monitoring of product sterilization processes in compliance with applicable industry standards. The role will support new product development, manufacturing operations, sterile implant/instrument processing, and microbiology laboratory activities.
Key Responsibilities:
- Review sterilization records and support sterility release of sterile implants.
- Support classification of new and modified medical devices.
- Execute sterilization validation, process improvement, and special projects.
- Support cleanroom, environmental monitoring, microbiology, and instrument reprocessing activities.
- Collaborate with Quality, Manufacturing, R&D, and other cross-functional teams on manufacturing issues and investigations.
- Prepare validation protocols, work instructions, technical reports, and related documentation.
- Provide technical support on microbiology, cleanroom technology, sterilization, and reprocessing.
- Support compliance with applicable AAMI and industry sterilization standards .
Qualifications:
- B.S. in Microbiology, Biology, Medical Technology, Engineering , or a related field.
- 0–3 years of relevant industry experience , preferably in medical devices, pharmaceuticals, or biotech.
- Knowledge of sterilization, sterility assurance, microbiology, cleanrooms, and process validation preferred.
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.
Company Description
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.
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