Microbiologist I
Job Summary
Imagine how your ideas and expertise can change a patients life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
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
Other incidental duties assigned by Leadership
What youll need (Required):
Bachelors Degree in In Microbiology 1 year experience in a microbiology environment preferred
What else we look for (Preferred):
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving 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
Advanced proficiency in Microsoft Office Suite including Word Excel and PowerPoint
Good written and verbal communications skills
Good problem-solving skills
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
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
Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
Required Experience:
IC
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more