Pharma Microbiology LIMS Expert – GMP Compliance

ISPE International; Lincolnshire (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Professional growth opportunities

Paid time off

Job summary

SGS is seeking a Pharmaceutical Microbiology LIMS Analyst to translate lab microbiology processes into validated LabVantage LIMS solutions. You will design compliant workflows covering sterility, bioburden, endotoxin, environmental monitoring, and microbial identification while partnering with QC, QA, Validation, and IT teams.

You will lead system configuration, validation support, and regulatory compliance efforts (USP/EP/BP/JP; 21 CFR Part 11; data integrity).

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology.
• 5+ years of GMP pharmaceutical laboratory experience.
• Experience with USP, EP, JP, and BP methods; sterility testing; bioburden; endotoxin; environmental monitoring; microbial identification; and method suitability studies.

Responsibilities

• Configure and maintain LabVantage LIMS for pharmaceutical microbiology testing.
• Develop and support test templates, specifications, sampling plans, calculations, and approval workflows.
• Translate regulatory requirements into system configurations and functional specs.
• Support system validation activities including IQ/OQ/PQ and computer software assurance.
• Ensure GMP, 21 CFR Part 11, data integrity, and GDP compliance.
• Collaborate with QC Microbiology, QA, Validation, and IT for methods and enhancements.
• Support regulatory inspections, audits, and computer system validation activities.
• Harmonize microbiology methods and workflows across laboratories.
• Provide guidance, troubleshooting, and ongoing user support for LabVantage.

Skills

LIMS Knowledge

Regulatory knowledge

Project coordination

GMP familiarity

Analytical thinking

Education

Bachelors or Masters in Microbiology/Pharmaceutical Sciences/Biotechnology

Tools

LabVantage LIMS Application

Test templates

Specifications

Sampling plans

Calculations

Stability workflows

Results entry & approvals

Job description

SGS is seeking a Pharmaceutical Microbiology LIMS Analyst to translate lab microbiology processes into validated LabVantage LIMS solutions. You will design compliant workflows covering sterility, bioburden, endotoxin, environmental monitoring, and microbial identification while partnering with QC, QA, Validation, and IT teams.

You will lead system configuration, validation support, and regulatory compliance efforts (USP/EP/BP/JP; 21 CFR Part 11; data integrity).