Edwards Lifesciences Microbiologist I in Cartago, Costa Rica
Set parameters of complex laboratory instrumentation to perform testing by applying microbiology knowledge and concepts.
Key Responsibilities: • Conduct studies to establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols • Identify basic testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards • Develop protocols, reports, and methods in collaboration with inter-departmental teams • Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing • Participate in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval • Collect samples for studies • Create and develop validation plans for laboratory equipment and methods • Investigate and perform lab corrective and preventative actions (CAPA) testing • Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes • May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures • Other incidental duties assigned by Leadership
Education and Experience: Bachelor's Degree in in Microbiology , 2 years years experience years of previous experience in a microbiology environment Required or Master's Degree or equivalent in in Microbiology no related experience Required Other: Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls Required
Additional Skills: • Proven expertise in MS Office Suite • Good written and verbal communication skills and interpersonal relationship skills • Demonstrated problem-solving and critical thinking skills • Good knowledge and understanding of Edwards policies and procedures relevant to microbiology • Good knowledge and understanding of microbiology principles, theories and concepts • Good understanding of at least one of the following areas: sterilization process, final release testing, and environmental controls • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing • Strict attention to detail • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast paced environment • Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.