Microbiology & Steril Specialist 1 CR Alajuela, Costa Rica + **Education** **/** **Educación** **:** University degree: University Bachelor's degree in microbiology, biotechnology engineering, or related career. + **Desirable:** + Experience in the Microbiology and Sterilization for medical devices. + Knowledge on FDA regulations, ISO 13485, ISO 14644, ISO 14698, ISO 11135, ISO 11137, ISO 10993-7, ISO 17665, AAMI ST 72, TIR 28, TS 13004, and related ISO and AAMI standards. + Operation, validation and adoption sterilization processes. + Experience in transfer or new product introduction projects. + **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible)** **:** + Preparation of microbiological cultures. + Aseptic techniques. + Environmental and microbiological testing: related to monitoring of controlled areas, water, product bioburden. + Preparation and testing of biological indicators for sterilization processes + **Languages** **​​** **required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):** Spanish/English (Advanced) + **Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:** + Basic Microsoft Office package: Advanced + MS Project: Intermediate + MS Visio: Basic + Minitab: Basic + **Qualifications** **/ Cualificaciones** **:** + Drive for Results + Planning + Organizational Agility + Listening + Decision Quality + Problem Solving **Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:** + Plan, coordinate and monitor the environmental monitoring program of controlled environment rooms, laundry, laminar flow hoods, air and water systems. + Coordinate routine microbiology analysis with external laboratories. + Coordinate with vendors such as sterilizers and external microbiology laboratories, for different special testing requirements. + Support/lead sterilization projects. + Support or plan and execute cost and/or time effective continuous improvement initiatives for the Microbiology Lab and the routine activities performed. + Plan and lead microbiological validations. + Plan, coordinate or perform the dose audits and bioburden programs. + Support or lead sterilization process requalifications or/and Annual Sterilization Assessment. + Support and execute assessments related to sterilization processes + Develop new microbiology methodologies for the Microbiology Laboratory. + Execute change orders. + Approve and support validations and risk analysis + Support or lead Microbiology investigations related to NCEs, OOTs, IACAs and CAPAs. + Product release support regarding events related to sterilization parameters or deviation events. + Support/lead impact assessments related to changes that could affect the effectiveness of the sterilization process. + Create Purchase Orders for services, supplies and others, and verify invoice payment. + Ensure availability of laboratory supplies, product samples, and culture media to perform microbiological and sterilization testing. + Coordinate and perform Training Programs for GMPs.