Senior Microbiologist

Key Responsibilities:

• Develop project plan, assemble team to conduct studies to establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols
• Compose protocols for sterilization or system validation/ sterility and antimicrobial controls; monitor and recommend controls for manufacturing environments, systems, and sterilization processes
• Identify complex testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards
• Develop complex protocols, reports, and methods in collaboration with interdepartmental teams
• Collect samples for studies
• Lead lab and manufacturing corrective and preventative actions (CAPA) testing
• May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
• Lead 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
• Make recommendations and validate new laboratory equipment
• Other incidental duties assigned by Leadership

Education and Experience:

Bachelor's Degree in In Microbiology, 4 Years years experience experience in a microbiology environment Required or
Master's Degree or equivalent in In Microbiology, 2 Years years experience related experience Required and
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 Preferred

Additional Skills:

• Excellent computer skills in usage of MS Office and Analytical Equipment System
• Excellent problemsolving and critical thinking skills
• Full knowledge and understanding of Edwards policies and procedures relevant to microbiology
• Full knowledge and understanding of microbiology principles, theories and concepts
• Expertise in one of the following areas: sterilization process, final release testing, and environmental controls
• Excellent written and verbal communications skills
• Advanced problemsolving skills
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness

About Edwards Lifesciences

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.

COVID Vaccination Requirement

For United States Applicants Only:

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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Workplace Discrimination is Illegal Poster
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Pay Transparency Notice

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