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- Develops sterilization strategies for disposable blood devices, implementing a tiered risk-based approach to establish regulatory compliance in support of new product development and registration for sterility studies.
- Plans and manages sterilization plans, testing and/or rationales based on changes in manufacturing, supplier information, material, etc changes to medical devices.
- Review, interpret, and summarize raw data from Contract Research Organization reports and documents biological assessments using sound scientific principles.
- Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, and GLP.
- The Microbiologist will be responsible for ensuring effective sterilization processes and compliance to all related standards for all Haemonetics products.
- This position will be responsible for execution of technical strategy including writing of protocols and reports, collaboration with external sterilization resources and direct interaction with all Haemonetics manufacturing plants.
- Timely disposition of any sterilization and environmental monitoring issues that could impact Haemonetics supply chain is a priority for this role.
- The ideal candidate should have experience in working with EtO, Gamma, Ebeam and steam sterilization processes with full understanding of all related international standards.
- Preferred experience with the following standards: ANSI/AAMI ST72, ISO 11135, ISO 11737, ASTM E3251, ASTM E3244, ISO 15747, ISO 11607 and European Pharmacopeia.
- Interact closely with and provide consultative direction to Quality, R&D, Clinical, and Regulatory Affairs within Haemonetics.
- Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets.
- 5+ years of experience with a Bachelor's degree, in Microbiology, Science, Engineering, Biology, Chemistry, 3+ years of experience with an MS degree or 1+ years' experience with a PhD.
- Experience in years as specified above in sterilization studies development, planning, execution and documentation.
- Functional expert in the sterilization principles of disposable medical devices.
- Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of sterility standards for blood disposable products.
- Ability to work independently to develop, execute and document sterilization studies.
Senior Sterilization Engineer - Simpang Ampat, Malaysia - Haemonetics
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We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
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