ScovaiJobsIS
Integrated Services For Productivity & Validation, Inc
Microbiologist - Medical Devices
Dorado, PRSur siteContratTemps plein
Publié 2 oct. 2026
Cet emploi est publié en ES
- Lead and support Investigations (ex. OOS, Environmental excursions, adverse trending, etc.)
- Write protocols and reports (Qualifications and Re-qualifications, ex. Clean Rooms & Equipment)
- Strong knowledge of ISO 14644, 13485, 11737 and FDA regulations
- Create/Revise Lab procedures
- Knowledge in ISO Class 8 clean rooms
- Knowledge in Environmental testing (BET, Bioburden, Air, Surface, etc.)
Requirements
- BS in Microbiology, Biology, Science (highly preferred Microbiology)
- More than 10 yrs of experience.
Aperçu du poste
Type de poste
Temps plein
Compétences requises
Investigation Management (OOS, environmental excursions, adverse trending)Root Cause AnalysisProtocol and Report Writing (Qualifications and Re-qualifications)Cleanroom Qualification and Re-qualification (rooms and equipment)ISO 14644 knowledgeISO 13485 knowledgeISO 11737 knowledgeFDA regulatory complianceSOP and Laboratory Procedure Creation/RevisionISO Class 8 cleanroom operationsEnvironmental testing – BioburdenEnvironmental testing – Bacterial Endotoxin Test (BET)Environmental monitoring – Air and surface samplingApplied Microbiology (laboratory-based microbiology expertise)
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