Senior Microbiologist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
We recently announced plans to expand in Spain by building a new state-of-the-art manufacturing plant in Moncada Valencia. When it becomes operational in 2026 the plant will manufacture Edwards surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1500 dedicated team members by 2029 across manufacturing engineering and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring with specialized training for manufacturing hires beginning in the fall of 2025.
How you will make an Impact:
Provide microbiological and chemistry testing services
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
What you will need (required):
Bachelors Degree in In Microbiology with 4 years experience experience in microbiology environment; or
Masters Degree or equivalent in Microbiology with 2 years experience related experience
What else we look for (preferred):
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
Proven expertise in MS Office Suite
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated 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
Advanced proficiency in Microsoft Office Suite including Word Excel and PowerPoint
Excellent written and verbal communications skills
Advanced problem-solving skills
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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
Ability to manage competing priorities in a fast paced 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
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Virology
- FDA Regulations
- Infusion Experience
- Laboratory Procedures
- PCR
- Biotechnology
- Microbiology
- Quality Control
- GLP
- cGMP
- QA/QC
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
