Experteer Overview In this role you will support Edwards’ expansion in Spain by providing microbiology testing and calibration for sterilization and environmental controls. You will lead studies, develop protocols, and collaborate across teams to ensure sterilization and bioburden standards meet regulatory expectations. The role combines hands-on lab work with process improvement and CAPA activities to sustain high-quality medical devices. You will join a global network and contribute to a pivotal manufacturing expansion in Moncada.Compensaciones / Beneficios - Provide microbiological and chemistry testing services - Develop project plans and assemble study teams for sterilization, sterility, antimicrobial, and environmental control validation - Draft and monitor protocols for sterilization and system validation;
recommend controls for manufacturing environments - Lead complex testing approaches, investigations, and identification using Edwards and external standards - Develop protocols, reports, and methods with inter-departmental collaboration - Collect samples for studies and lead CAPA testing in lab and manufacturing - Set parameters for complex lab equipment for receiving inspection, raw materials, environment testing, and final product release - 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/modified devices or processes - Validate new laboratory equipment and perform other duties assigned by LeadershipResponsabilidades - Bachelor’s Degree in Microbiology with 4 years of microbiology experience or Master’s Degree in Microbiology with 2 years of related experience - experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, testing of medical devices, sterilization processes, and environmental controls - MS Office Suite proficiency - excellent written and verbal communication and interpersonal skills - problem-solving and critical thinking abilities - full knowledge of Edwards policies relevant to microbiology and microbiology principles - expertise in sterilization processes, final release testing, and environmental controls - knowledge of GMP and Good Documentation Practices in a medical device environment - professional interaction across organizational levels and capability to manage competing priorities - compliance with Environmental Health & Safety and quality guidelines for clean room production - pandemic protocols adherenceRequisitos principales -