The Opportunity This position works out of our Alajuela location.
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Sr Microbiologist II, you'll consistently apply microbiological concepts to the manufacturing process of a medical device and understand and develop process monitoring/metrics to maintain microbiological quality of the final device.What You'll Do Provides 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.
Master´s degree in Microbiology, Science, Administration or related.3-5 years of experience in a medical device/pharmaceutical, or related industry in microbiology and/or sterilization roles.Experience in environmental monitoring, process and product monitoring in a medical devices or pharmaceutical industry.Experience in Sterilization validation for Ethylene Oxide, Steam or Chemical sterilization processes.Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).Fully bilingual (English - Spanish).
