Senior GxP IT Analyst - Lab Systems & Validation Expert

MESO SCALE DIAGNOSTICS, LLC.; Rockville (MD); On-site; USD 117,000 - 178,000; Full time

Job summary

MESO SCALE DIAGNOSTICS, LLC. is seeking an experienced Senior IT GxP Technical Analyst to lead the design, development, and delivery of IT solutions for the Bioanalytical Laboratory. The role ensures GLP/GCLP and 21 CFR Part 11 compliance, translating lab workflows into validated, integrated systems.

You will partner with scientists, QA, cybersecurity, and vendors to set technical direction, own complex solutions end to end, and mentor other IT staff in validated delivery practices.

Qualifications

• Bachelor’s degree in IT, CS, IS, bioinformatics or related field; equivalent combination considered.
• Minimum 6 years designing, configuring, or developing computerized systems, with at least 3 years in GLP/GCLP.
• Experience delivering validated LIMS and laboratory data-system solutions.

Responsibilities

• Act as senior technical authority for Bioanalytical Laboratory systems and define roadmaps.
• Gather and translate lab requirements into user specifications and designs.
• Design, configure, and deploy GxP solutions for LIMS and instrument data systems.
• Lead end-to-end complex system initiatives with vendors and internal teams.
• Provide application support, root cause analysis, and incident escalation.
• Ensure solutions are inspection-ready and validated.

Skills

GxP compliance knowledge

LIMS integration experience

Lead technical delivery

Analytical troubleshooting

Communication with stakeholders

Education

Bachelor’s degree in Information Technology, Computer Science, Information Systems, Bioinformatics, or related discipline

Tools

LabWare

LabVantage

STARLIMS

Watson LIMS

SQL

APIs

Web services

Scripting language

Job description

MESO SCALE DIAGNOSTICS, LLC. is seeking an experienced Senior IT GxP Technical Analyst to lead the design, development, and delivery of IT solutions for the Bioanalytical Laboratory. The role ensures GLP/GCLP and 21 CFR Part 11 compliance, translating lab workflows into validated, integrated systems.

You will partner with scientists, QA, cybersecurity, and vendors to set technical direction, own complex solutions end to end, and mentor other IT staff in validated delivery practices.