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 integral network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 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):
- Bachelor's Degree in In Microbiology with 4 years experience experience in microbiology environment; or
- Master's 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