Senior Sterilization Engineer

Found in: Talent MY C2 - 1 week ago

Simpang Ampat, Malaysia Haemonetics Full time

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.

Job Details

Responsibilities:-

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.

Job Requirement

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.

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