What you will do- The Staff Microbiologist is responsible for performing microbiological testing using qualified laboratory equipment and procedures to ensure accurate and reliable results. This role also includes evaluating and approving microbiological testing data to ensure compliance with applicable methods and regulatory standards. Additionally, the position requires carrying out and completing sterilization validation processes as mandated by the specific project, adhering to current standards to guarantee effective sterilization procedures.
Responsibilities and Functions Ensuring all microbiology analysis of medical devices adheres to cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines specific to the project. Overseeing and contributing to the development and improvement of manufacturing processes for both existing and new products within the project.Leading the development, review, and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ) for the project. Acting as the subject matter expert and point of contact for suppliers concerning new process development, quality issues, and process improvements related to the project.Supporting the project during product transfers. Reviewing and approving product and process change control documentation and specifications for the project. Reviewing and approving documentation related to nonconforming materials and systems specific to the project.Mentoring team members involved in the project. Conducting laboratory testing such as bioburden, microorganism identification, growth promotion, and endotoxin testing using qualified equipment, following procedures applicable to the project.Conducting environmental sampling in manufacturing-controlled areas to support the monitoring program for the project. Preparing reports related to microbiological analysis, CA Monitoring Program, and monthly metrics for the project.Reviewing and approving microbiological testing data to ensure compliance with applicable standards and test methods for the project. Training new and existing personnel on Environmental Control Area controls and microbiology testing techniques related to the project. Ensuring laboratory equipment is qualified, calibrated, and part of the Preventive Maintenance (PM) program for the project. Conducting laboratory testing method qualification and equipment validations specific to the project.Providing support during audits (e.g., FDA, TUV) related to the project. Reviewing and approving reports of biological indicators or sterility analysis for the project. Supporting sterilization process validations for the project. Reviewing biocompatibility documents relevant to the project.Coordinating and managing testing conducted by external laboratories according to procedures for the project. Performing additional duties as required by operations and according to skills and abilities within the project. Complying with Health and Occupational Safety (EHS) policies relevant to the project.What you need- B.S. in Microbiology or Biology, or related discipline from accredited university. Communicate (read, write, and understand) in English and Spanish.At least 4+ years of experience with method validation experience preferable in medical devices.Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures.Demonstrated knowledge on the fundamentals of sterilization process.Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies.Experience conducting laboratory testingKnowledge in identification of microorganisms.Knowledge in microbiology lab equipment installation and operational qualification validations.
#J-18808-Ljbffr