Senior GxP IT Lead, LIMS & Lab Systems Validation

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

Benefits offered by this job

401(k) plan with company matching

Disability insurance (short/long-term)

Paid vacation and holidays

Parental leave

Job summary

Meso Scale Diagnostics LLC seeks a Senior IT GxP Technical Analyst to lead design, development, and delivery of validated lab IT systems. You will translate lab workflows into configured LIMS, instrument integration, and quality systems, ensuring 21 CFR Part 11 compliance.

You will oversee technical direction, end-to-end delivery of complex initiatives, and mentor IT staff, collaborating with QA, cybersecurity, and operations to maintain inspection-ready solutions.

Qualifications

• Requires bachelor’s degree in IT/CS or related field or equivalent experience.
• Minimum 6 years designing, configuring, or developing computerized systems.
• At least 3 years in a GLP/GCLP regulated environment.

Responsibilities

• Serve as senior technical authority for Bioanalytical Laboratory systems and set standards.
• Translate lab requirements into user specs, designs, and configurations.
• Design, configure, and deploy GxP solutions including LIMS and electronic records.

Skills

GxP compliance

SQL

System architecture

Documentation & QA

Education

Bachelor's degree in IT/CS or related

Tools

LabWare LIMS

LabVantage LIMS

STARLIMS

Job description

Meso Scale Diagnostics LLC seeks a Senior IT GxP Technical Analyst to lead design, development, and delivery of validated lab IT systems. You will translate lab workflows into configured LIMS, instrument integration, and quality systems, ensuring 21 CFR Part 11 compliance.

You will oversee technical direction, end-to-end delivery of complex initiatives, and mentor IT staff, collaborating with QA, cybersecurity, and operations to maintain inspection-ready solutions.