Experteer Overview As part of Edwards’ expansion in Spain, you will join a growing manufacturing hub focused on surgical and transcatheter heart valve technologies. In this role you will lead microbiology testing and process validation to support sterile product manufacture. You will collaborate across functions to establish robust sterilization, antimicrobial and environmental controls, and drive continuous improvement in lab and manufacturing systems. This is a high-impact opportunity to shape quality, compliance, and product reliability at scale.Compensaciones / Ventajas
- Provide microbiological and chemistry testing services
- Develop project plans and assemble teams to study sterilization levels and validation for sterility, antimicrobial and environmental controls; evaluate/update microbial protocols
- Create protocols for sterilization or system validation; monitor and recommend controls for manufacturing environments, systems, and sterilization processes
- Identify complex testing approaches for microbiological testing, investigations, isolation and identification per Edwards and external standards
- Develop complex protocols, reports, and methods with cross-department collaboration
- Collect samples for studies
- Lead lab and manufacturing CAPA testing
- Train, coach, and guide lower-level employees on new procedures when needed
- Set parameters of complex laboratory machines for receiving inspection, raw materials, environmental testing, and final product release testing
- Lead process improvement projects (BEST, Lean) and propose recommendations for management approval
- Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and processes
- Make recommendations and validate new laboratory equipment
- Perform other duties as assigned by LeadershipResponsabilidades
- Bachelor's in Microbiology with 4 years of microbiology experience
- Master's in Microbiology with 2 years of relevant experience
- Proven MS Office proficiencyRequisitos principales
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