Senior Information Technology GxP Technical Analyst

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

4d•$116,600 - $177,800

About The Position

This position leads the design, development, and delivery of IT solutions and applications supporting the company’s Bioanalytical Laboratory. It translates laboratory and scientific workflow requirements into configured, integrated, and validated computerized systems—including LIMS, instrument data systems, electronic records, and quality systems—and ensures compliance with GLP/GCLP and 21 CFR Part 11 standards. The Senior IT GxP Technical Analyst works closely with Bioanalytical Lab scientists and operations leadership, Quality Assurance, Cybersecurity, Enterprise Systems, software vendors, and the Senior IT GxP and Quality Compliance Analyst, who provides independent compliance oversight. As the senior technical authority for lab systems, the role sets technical direction and standards, owns complex solutions end to end, and mentors IT staff in validated delivery practices.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Information Systems, Bioinformatics, or a related discipline; an equivalent combination of education and experience is considered.
At least 6 years of experience designing, configuring, or developing computerized systems, including at least 3 years in a GLP and/or GCLP regulated environment.
Hands-on experience implementing, configuring, or administering a LIMS, such as LabWare, LabVantage, STARLIMS, or Watson LIMS, and integrating laboratory instruments or chromatography data systems.
Experience delivering solutions through a validated SDLC, including authoring specifications and executing IQ/OQ/PQ test scripts.
Demonstrated experience leading technical delivery of computerized system implementations or major upgrades, including vendor and stakeholder coordination.
Advanced knowledge of GxP compliance requirements for computerized systems, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.
Practical technical skills in configuration, scripting, and data work, including SQL, reporting tools, APIs and web services, and at least one scripting or programming language.
Strong understanding of system architecture, environments, interfaces, databases, and access and security models for validated applications.
Ability to translate scientific and laboratory workflows into technical designs and configured system behavior.
Disciplined documentation habits and ability to produce inspection-ready technical evidence as a normal part of delivery.
Strong analytical and troubleshooting skills, including root cause analysis of application and interface issues.
Strong technical judgment in deciding when to configure, customize, adopt vendor functionality, or standardize while balancing validation burden against business need.
Ability to make sound technical design decisions autonomously and justify them to compliance, Quality Assurance, and business stakeholders.
Ability to provide day-to-day guidance and mentoring in a supportive and collaborative manner.
Strong written and verbal communication skills, including explaining technical concepts and trade-offs to scientists, Quality Assurance, and non-technical stakeholders.

Nice To Haves

Experience working in an IT role in a high-throughput clinical research organization (CRO).
Experience with bioanalytical workflows, including sample lifecycle, assay runs, chain of custody, and study data reporting.
Experience mentoring or providing technical review for other IT staff.

Responsibilities

Act as senior technical authority for Bioanalytical Laboratory systems, set design, configuration, and integration standards, and own the technical roadmap for the lab application landscape.
Gather, analyze, and document business, laboratory, and data requirements, translating them into user requirement specifications, functional designs, and configuration specifications.
Design, configure, develop, and deploy GxP solutions for sample management, testing workflow management (LIMS), instrument integration, electronic records, and quality system management.
Execute technical system lifecycle activities, including environment builds and configuration management, code and configuration version control, unit and integration testing, and authoring and executing IQ/OQ/PQ test scripts.
Produce technical validation documentation, including design specifications, configuration records, traceability, and test evidence, to meet IT Compliance and Quality Assurance approval standards.
Manage technical change controls and releases, ensuring changes are risk-assessed, tested, documented, and promoted only through approved, validated pathways.
Lead complex or multi-system initiatives end to end, including effort estimation, technical planning, coordination of internal resources and software vendors, and technical decision-making.
Provide application-level support and troubleshooting for GxP systems, perform root cause analysis, resolve defects, and escalate incidents with data integrity impact to IT Compliance and Quality Assurance.
Support vendor-delivered upgrades, patches, and platform releases, including impact assessment, regression testing, and coordination with software suppliers.
Partner with IT Compliance, Quality Assurance, and lab scientists to ensure solutions are fit for purpose, inspection-ready, and maintained in a validated state.