Lead GxP IT Lab Systems Analyst

Meso Scale Diagnostics; Rockville (MD); Hybrid; USD 117,000 - 178,000; Full time

Job summary

MESO Scale Diagnostics in Rockville, MD seeks a Senior Information Technology GxP Technical Analyst to lead design, implementation, and validation of Lab IT systems. You will shape technical standards for LIMS, instrument data, electronic records, and quality systems, ensuring GLP/GCLP and 21 CFR Part 11 compliance.

You will partner with scientists, QA, cybersecurity, and vendors, providing end-to-end technical leadership and mentoring staff in validated delivery practices within a hybrid,

Qualifications

• Requires Bachelor’s degree in IT/CS/IS or related field; equivalent experience considered.
• Minimum 6 years designing, configuring, or developing computerized systems in GLP/GCLP contexts.

Responsibilities

• Act as senior technical authority for Bioanalytical Lab systems and own the technical roadmap.
• Gather, analyze, and document requirements; translate into specs and configuration definitions.
• Design, configure, develop, and deploy GxP solutions for LIMS, instrument data systems, and quality systems.
• Execute system lifecycle activities: environment build, version control, testing, IQ/OQ/PQ scripts.
• Produce validation documentation and ensure audit trails align with IT Compliance and QA.
• Manage change controls and validated release pathways; coordinate with vendors.

Skills

GxP compliance

SQL

APIs

Scripting

Education

Bachelor’s degree in IT / CS / IS

Tools

LabWare

LabVantage

STARLIMS

Watson LIMS

Job description

MESO Scale Diagnostics in Rockville, MD seeks a Senior Information Technology GxP Technical Analyst to lead design, implementation, and validation of Lab IT systems. You will shape technical standards for LIMS, instrument data, electronic records, and quality systems, ensuring GLP/GCLP and 21 CFR Part 11 compliance.

You will partner with scientists, QA, cybersecurity, and vendors, providing end-to-end technical leadership and mentoring staff in validated delivery practices within a hybrid,