Principal Microbiologist (Sterilization)

Good decisions are rooted in good data. Founded in Edwards Lifesciences’ strong ethical culture, our commitment to best practice in data governance ensures accuracy, consistency and integrity of data at all levels. This critical function harmonizes data governance policies and processes in collaboration with business units and functions across the globe. You’ll have the resources needed to ensure we are holding ourselves to the highest standards possible. In addition, address complex compliance and risk assessment activities related to new product development and manufacturing sustaining activities as it relates to sterility assurance. How you will make an impact: • Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams • Provide strategy and guide other teams on root cause analysis for failures, non-conformances, deviations, and corrective and preventative actions • Train, coach, and guide employees on complex sterilization processes and test methods, assess work techniques, and provide feedback on policies and procedures • Provide solutions and lead in the validation of new sterilization processes • Lead complex critical system improvement projects (e.g. BEST, Lean) and work with team to provide solutions • May be a on a working group/committee in support of a compliance guide • Work closely with contract sterilization facilities to address capacity, technical issues, validation, scheduling, audits, and on-boarding • Provide technical expertise in Ethylene Oxide, Gamma, E-beam, moist heat (steam), and other methods of sterilization. • Other incidental duties: What you'll need (Required): • Bachelor's Degree and 8 years of previous related experience in medical device and/or pharmaceutical fields OR • Master's Degree and 6 years of previous related experience in medical device and/or pharmaceutical fields OR • Ph.D. or Equivalent and 4 years of previous related experience in medical device and/or pharmaceutical fields. What else we look for (Preferred): • Expertise in EO sterilization related standards including ISO 11135 • Expertise in radiation sterilization related standards including ISO 11137 series • Expertise in EO residual related standards including ISO 10993-7 • Strong leadership skills and ability to influence change • Ability to interact professionally with all organizational levels • Ability to manage confidential information with discretion • Excellent facilitation and presentation skills • Excellent written and verbal communications skills • Strict attention to detail • Advanced problem-solving skills • Excellent problem-solving, organizational, analytical and critical thinking skills • Excellent communication and interpersonal relationship skills including negotiating and relationship management with ability to drive achievement of objectives • Extensive knowledge and understanding of Microbiology principles, theories and concepts. • Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, AAMI, GLP/GMP) • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment • Proven successful project management skills of multiple projects at a time • Ability to manage competing priorities in a fast-paced environment • Ability to work in a team environment, including frequent inter-organizational and outside customer contacts • Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects • 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 • Extensive knowledge and understanding of Edwards’ policies and procedures relevant to microbiology which includes contamination control and sterilization. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination. 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 15,000 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.