IS
Integrated Services For Productivity & Validation, Inc
Microbiologist - Medical Devices
Dorado, PRPresencialContratoTiempo completo
Publicado 2 oct 2026
- 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.
Resumen del puesto
Tipo de empleo
Tiempo completo
Habilidades requeridas
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)
Empleos similares
IS
Engineer - 35844
Integrated Services For Productivity & Validation, Inc
Juncos, PRPresencialContratoTiempo completo
hace 9 horas
QG
Investigations Lead
QRC Group
Manati, PRPresencialContratoTiempo completo
hace 9 horas
QG
Engineer
QRC Group
Juncos, PRPresencialContratoTiempo completo
hace 9 horas
IR
Technicien de laboratoire et contrôle qualité
INAL Ressources
Candiac, CAPresencialContratoTiempo completo
hace 9 horas
QG
Specialist QA
QRC Group
Juncos, PRPresencialContratoTiempo completo
hace 9 horas
Berufsausbildung Fachkraft für Lagerlogistik (w/m/d)
STIHL Vertriebszentrale AG & Co. KG
Dieburg, DEPresencialContratoTiempo completo
hace 10 horas