Overnight Associate Scientist
Core
Collect and test routine environmental monitoring samples and utility samples in aseptic processing fill lines, isolators, and clean rooms to ensure compliance with cGMP and GLP standards.
Role type
Associate Scientist (Environmental Monitoring)
Builds
Environmental monitoring data for critical system release and utility sample quality assurance
Domain
Pharmaceutical manufacturing / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Environmental monitoring, aseptic technique, media preparation, sub-culturing, Gram-staining, bioburden testing, endotoxin testing, TOC testing, conductivity testing, LIMS data entry, documentation compliance
Preferred skills
Experience in pharmaceutical or related laboratory industries
Technologies
LIMS, Laboratory Information Management System
Responsibilities
Perform environmental monitoring for non-viable and viable airborne particulate, bioburden, and surface contamination; Collect and process utility samples (WFI, clean steam, compressed gases); Perform bioburden, endotoxin, TOC, and conductivity testing; Maintain temperature records, lab cleaning records, and logbooks; Input results into LIMS and track microbiological results; Compile and submit environmental monitoring data for critical system release; Support Scientist/Lead Scientist/Supervisor with testing and special projects; Aid with plant and laboratory equipment re-qualifications; Report data discrepancies and out of limit conditions; Assist in training new departmental personnel; Maintain compliance with company policies, training requirements, and cGMPs.
Seniority
Entry to Mid-level, hands-on IC
