• 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
• Create and develop validation plans for laboratory equipment and methods
• Collect samples for studies
• Develop protocols, reports, and methods in collaboration with inter-departmental teams
• Investigate and perform lab corrective and preventative actions (CAPA) testing
• 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
• 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
**Required Education/Skills/Experience** :
• Bachelor’s Degree or equivalent Microbiology or related science field with no previous experience Required or
• Other: Diploma in Microbiology or related science field 3 years of previous experience in a microbiology environment 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
• Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment.
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving skills
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Microbiologist I
Job Number: 017103