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
R/ D Engineer - North Puerto Rico Region
Integrated Services For Productivity & Validation, Inc
Dorado, PRPresencialContratoTiempo completo
hace 3 horas
QG
Specialist QA
QRC Group
Juncos, PRPresencialContratoTiempo completo
hace 3 horas
North America Business Development Manager
HR Business Solutions
Madison, USPresencialContratoTiempo completo
hace 9 horas
Full Stack Java Developer (Contract)
CoreFactor Inc.
North York (Hillcrest Village), CAPresencialContratoTiempo completo
hace 23 horas
Management Accountant - Retail Sector
HR Business Solutions
Islamabad, PKPresencialContratoTiempo completo
ayer
Assistant Manager - Pre-Audit (HVAC Industry)
HR Business Solutions
Karachi, PKPresencialContratoTiempo completo
ayer