Microbiology Engineer

Essential Duties and Responsibilities • Monitor processes to identify trends and adverse conditions, taking the lead in implementing corrective action. • Compiled and analyzed reporting data for approval and release in a timely manner. • Ensures Good Manufacturing Practices, GMPs and GDPR are met for sterilization by DHRS, performing additional audits to verify efficiency and suitability. Must be able to generate management reports for such status and conditions. • Ensure standard operating procedures comply with FDA QSR, MDD and applicable international standards • Evaluate environmental monitoring reports on a monthly and quarterly basis, making decisions or implementing solutions to control and improve conditions • Coordinate sample testing to a qualified external laboratory, and ensure results are received in a timely manner and specify that requirements are met. Also responsible for communicating with the outside laboratory or shipping company if necessary to achieve business objectives. • Responsible for developing responses and corrective action plans for sterilization and microbiological non-conformities resulting from external audits. • Develop processes and procedures for routine sterilization control that is in compliance with regulations, external standards and corporate policies. • Ensure all calibrations and validations of current equipment microbiology. • Examines and verifies pyrogen testing being conducted and reports per formal procedures and standards. • Responsible for developing microbiological and corrective action plans and responses for sterilization non-conformities resulting from internal external audits. • Audits and maintains Quality Management System related to microbiological sterilization and conditions. Knowledge and Skills • Practical knowledge of Microbiology, sterility testing principles and techniques. • Basic knowledge of applied science, laboratory sciences and statistical techniques. • Demonstrated knowledge and ability to use sterilization and testing equipment. • Demonstrated skill in performing aseptic sterilization testing and operating laboratory equipment. • Demonstrated ability to work under stress and demanding schedules. • Established ability to perform precision environmental, airborne, and surface loading bio-assay testing, and other analyses as required. Confirmed analytical ability to analyze test results. • Perform routine good manufacturing practices and hygiene controlled environment audits. Reports issues and follows up on agreed actions in a timely manner. • Ensures validation and testing plans meet regulatory requirements. • Sterilization and approval of monthly management reports. Minimum Qualifications, Education and Experience • Engineering Degree from accredited university • 2-5 years similar role in Medical device industry experience • Demonstrated experience of compliance with standards and regulation such as FDA and ISO 13485. • Excellent Spanish/English communication skills both written and verbal

Location: Baja California, MX

Posted Date: 4/26/2025