The OpportunityThis position works out of our Alajuela location.
As the Microbiologist II, you'll apply microbiological concepts to the manufacturing process of a medical device and understand process monitoring to maintain microbiological quality of the final device.What You'll DoProvides Facility Microbiological SupportRecord review of routine microbiological test resultsRoutine release of manufactured productTechnical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.Handles routine out of specification test results, or more complex out of specification issues.Data analysis of sterilization processes.Participate in audits of sterilization, test lab, and biological product vendors.DocumentationEnsures correct documentation linkage flow for microbiologically related documents.Writes new or updates current microbiologically related documents.Maintains understanding of applicable standards and applies them to qualifications and test methods.Writes protocols and reports for qualifications for sterilization and microbiological test methods.Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.Develops sterilization cycles and laboratory test methods.
Works with technicians in conducting these qualifications.Techincal trainingProvides training to laboratory technicians on new equipment or new test procedures.Provides training in the areas of sterilization validation and sterilization processes.Authority to sign off Qualifications, DDAs, NCMRs, COs, FMEAs, PDP forms.Member of R&D product teams, Operations project teams, or supports other projects as Directed by Department Manager.Required QualificationsBachelor's in Microbiology or related field.2 years of working experience on similar roles as a Microbiologist.Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).Articulates microbiology technical concepts well.Must have knowledge of Good Laboratory Practices (GLP's), Bacteriology and use of lab equipment such as Laminar Flow Hoods, as Autoclaves, Incubators, pH meter, analytical balance, etc.Advance Commands of English required.Preferred QualificationsExperience working in a cross-division business unit model, preferred.
