Sterility Assurance Engineer
A Sterility Assurance Engineer ensures products, especially medical devices, meet required sterility
standards throughout their lifecycle. This involves applying best practices, regulations, and standards related to contamination control and sterilization methods during product development,
manufacturing, and sterilization validation. They also play a crucial role in ensuring regulatory
compliance and driving innovation in sterility assurance practices.
Key Responsibilities:
Contamination Control and Sterility Assurance:
Provide technical leadership in these areas, ensuring products are manufactured and sterilized
according to regulations and standards.
Sterilization Validation:
Apply best practices in the selection, investigation, and validation of sterilization methodologies,
including methods like Ethylene Oxide (EO), Gamma Radiation, and Steam.
Regulatory Compliance:
Support regulatory submissions, ensure design changes meet requirements, and participate in due
diligence for acquisitions and licensing.
Process Improvement:
Drive innovation in sterilization processes, develop validation procedures for cleaning and
sterilization of reusable devices, and support the development of manufacturing instructions.
Environmental Monitoring and Testing:
Support environmental monitoring programs and sterility assurance testing, including the review of biological indicator test results and supporting sterilization validations.
Collaboration:
Work with various teams including product development, operations, and regulatory affairs,
providing expertise and guidance on sterility assurance matters.
Auditing:
Conduct audits of contract sterilization vendors and laboratories.
Deviation Management:
Manage deviations related to sterility assurance using quality assurance tools like planned deviations and change control systems.
Training:
Provide training on GMP and other relevant procedures related to sterility assurance.
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