Senior Analyst, Pharmaceutical Microbiology LIMS
Core
Subject matter expert translating pharmaceutical microbiology laboratory processes into validated LabVantage LIMS solutions to support sterility, bioburden, endotoxin, and environmental monitoring programs.
Role type
Senior IC pharmaceutical microbiology LIMS analyst
Builds
Validated LIMS workflows and configurations for GMP microbiology testing
Domain
Pharmaceutical manufacturing / Regulatory compliance (GMP, 21 CFR Part 11)
Deliverable
production ML models | product features | dashboards & analysis
Required skills
LabVantage LIMS configuration, GMP microbiology testing, system validation (IQ/OQ/PQ), regulatory compliance (USP, 21 CFR), data integrity principles, test method development, workflow standardization
Preferred skills
None stated
Technologies
LabVantage LIMS
Responsibilities
Configure and maintain LabVantage LIMS functionality for pharmaceutical microbiology testing; Develop and support test templates, specifications, sampling plans, calculations, and approval workflows; Translate laboratory and regulatory requirements into system configurations and functional specifications; Support system validation activities including requirements documentation, testing, traceability, and qualification protocols; Ensure compliance with GMP, 21 CFR Part 11, data integrity principles, and global pharmacopoeial requirements; Collaborate with QC Microbiology, Quality Assurance, Validation, and IT teams to implement new methods and system enhancements; Support regulatory inspections, audits, and computer system validation activities; Drive the harmonization and standardization of microbiology methods and workflows across laboratories; Provide technical guidance, troubleshooting, training, and ongoing support to LabVantage users
Seniority
Senior, hands-on IC
