Edwards Lifesciences

Senior Microbiologist

1 week agoSingapore

Set parameters of complex laboratory instrumentation to perform testing by applying microbiology knowledge and concepts.

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 inter-departmental 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
• 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
• 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 or equivalent in Microbiology or related science field with, 6 Years years experience of previous experience in a microbiology environment Required or
Other: in Diploma in Microbiology or related science field with, 4 Years years experience previous experience in a microbiology environment Required
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:
• Excellent computer skills in usage of MS Office and Analytical Equipment System
• Excellent problem-solving 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 problem-solving skills
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• 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
• 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