Microbiologist 2
Core
Independently perform microbiological testing, lead investigations, and ensure compliance of microbiology laboratory and environmental monitoring programs for medical device manufacturing.
Role type
Senior IC microbiologist (medical devices)
Builds
Medical devices (continuous glucose monitoring systems)
Domain
Medical devices / Biopharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological testing, Environmental monitoring, Gram staining, Microbial identification, Bacterial endotoxin testing, Sterility testing, Bioburden recovery, SOP execution, cGMP compliance, Risk assessment, Validation protocols, Supplier audit support
Preferred skills
Medical device industry experience, Knowledge of 21 CFR 820/ISO 13485/US-EU Pharmacopeia, Sterilization testing, Biocompatibility testing, Implantable device experience
Technologies
HVAC systems, Cleanroom systems, Compressed air/gas systems, Pharmaceutical-grade water systems, Laboratory equipment
Responsibilities
Coordinate environmental monitoring programs for cleanrooms and utility systems; Conduct laboratory testing including sterility and endotoxin assays; Troubleshoot microbiological and environmental monitoring activities; Manage laboratory inventory and coordinate with contract labs; Support validation, technology transfer, and procedure development; Review and approve environmental monitoring data and documentation; Participate in internal and external audits.
Seniority
Mid-Senior, hands-on IC
