Senior Microbiologist
Core
Technical leadership for sterilization, sterility assurance, antimicrobial control, and environmental monitoring programs supporting medical device manufacturing.
Role type
Senior Microbiologist (Quality/Regulatory)
Builds
Medical device manufacturing processes and sterile environments
Domain
Medical Devices / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology principles, Sterilization methods, Environmental monitoring, Validation protocols, Root cause analysis, Regulatory compliance (FDA/GMP/ISO), SOP development, Data analysis, Aseptic technique, Hazardous material handling
Preferred skills
LIMS software, WinKQCL, Advanced Microsoft Office, Change impact assessment, Cleanroom design knowledge
Technologies
LIMS, WinKQCL, Microsoft Office Suite
Responsibilities
Lead cross-functional validation and qualification studies, Perform and approve routine and non-routine microbiological testing, Provide authoritative guidance on atypical results and OOS/OOT trends, Lead microbiology related investigations and corrective actions, Author and review microbiology SOPs and protocols, Support internal and external audits and inspections, Mentor technicians and junior microbiologists
Seniority
Senior, hands-on IC with technical leadership