Microbiology & Steril Analyst 2 CR Alajuela, Costa Rica + **Education:** University degree: 50% University Bachelor's degree in microbiology, biotechnology engineering, or related career. + **Specialized Knowledge (Desirable):** + 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 + FDA regulations, ISO 13485, ISO 14644, ISO 14698, ISO 11135, ISO 11137, TIR 28, TS 13004, and related ISO and AAMI standards. + Operation, validation and adoption sterilization processes. + Experience in transfer or new product introduction projects + **Languages ​​required for the position (Desirable):** Spanish/English (Advanced) + **Computer tools and knowledge level required (Desirable):** + Basic Microsoft Office package: Advanced + MS Project: Advanced + MS Visio: Advanced + Minitab: Basic + **Qualifications:** + Organizational Agility + Listening + Decision Quality + Problem Solving + Drive for Results + Planning + **Summary of Duties and Responsibilities:** + 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.