Sr Microbiologist
hace 2 semanas
The Opportunity
This position works out of our Alajuela location in the Structural Heart Business Unit. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
As the Sr Microbiologist, 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 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. Technical 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. Occasional supervising of technical employees at the laboratory may apply to the role.Required Qualifications
Bachelor's in microbiology or related field. 3-5 years of working 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). Articulates microbiology technical concepts well. Advance Commands of English required. Available to work 100% on site (Coyol, Alajuela). Shift Administrative (Monday to Friday 8:00 am -5:00 pm).Preferred Qualifications
Experience working in a cross-division business unit model, preferred. Master ́s degree in microbiology, science, administration or retaled. Supervising experience.-
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