Scientist, Analytical R&D
Core
Perform environmental monitoring, utility testing, and microbiological analysis in a GMP-compliant laboratory to ensure product quality and facility sterility.
Role type
Scientist, Analytical R&D (Microbiologist)
Builds
Data for finished product testing, environmental monitoring, and utility system validation
Domain
Pharmaceutical manufacturing / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology laboratory practices, Environmental Monitoring, Aseptic sampling techniques, Microbial identification, Endotoxin testing, GMP compliance, Data integrity (ALCOA), Root cause analysis, CAPA development
Preferred skills
Sterile manufacturing experience, Quality investigations, LIMS usage
Technologies
RODAC plates, Isolator/BSC, Veeva, SAP, MODA
Responsibilities
Perform viable and non-viable environmental monitoring of cleanroom areas; Conduct active and passive air sampling and surface sampling; Operate and maintain EM instruments; Execute aseptic sampling and utility sampling/testing; Perform microbiology laboratory testing including bioburden and endotoxin; Trend and analyze EM data; Participate in deviation investigations and CAPA development; Maintain accurate documentation; Conduct finished goods testing and sterility testing; Support compliance audit activities
Seniority
Mid-level, hands-on IC