What are the responsibilities and job description for the Principal Microbiologist position at Edwards Lifesciences Corporation?
Imagine how your ideas and expertise can change a patient's 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. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. In this role you will address complex compliance and risk assessment activities related to new product development and manufacturing sustaining activities as it relates to contamination control and sterility assurance.
How you will make an impact :
- Qualify complex laboratory instrumentation and validate complex test methods while applying microbial knowledge and concepts to perform environmental control testing, in-process solutions, and final product release testing for device qualifications
- Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams
- Provide strategy and guide other microbiologists on root cause analysis for product / sample failures, Out-of-Specifications (OOS), non-conformances investigations
- Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
- Lead laboratory manufacturing sustaining operations activities including maintaining work schedules to align with production
- Provide solutions and lead in the validation of new laboratory equipment
- 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
- Other incidental duties :
What you'll need (Required) :
What else we look for (Preferred) :
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.