Senior IT GxP Technical Analyst

Title

Senior IT GxP Technical Analyst

Location

Rockville, MD (hybrid preferred, open to remote for exceptional candidates)

Target Start Date

ASAP

Type

Direct-Hire

Salary / Pay Rate

DOE

Why Work Here

This is an established life sciences company with a bioanalytical laboratory at the center of its work, and this role builds the systems that lab runs on. You would be the senior technical authority for lab systems, setting standards and owning the technical roadmap rather than just maintaining what is already there. The work puts you side by side with scientists, Quality Assurance, and cybersecurity, so you see the direct impact of your solutions on the science. You would also mentor other IT staff in validated delivery, making this a strong fit for someone ready to lead technically. It is a stable, regulated environment that values disciplined documentation and doing things right.

About the Role

This role leads the design, development, and delivery of the IT solutions and applications that run the company's bioanalytical laboratory. The analyst translates laboratory and scientific workflow requirements into configured, integrated, and validated computerized systems, including LIMS, instrument data systems, electronic records, and quality systems, while making sure GLP/GCLP and 21 CFR Part 11 standards are met. The position works closely with lab scientists and operations leadership, Quality Assurance, Cybersecurity, Enterprise Systems, software vendors, and a GxP compliance partner who provides independent oversight of delivered solutions. As the senior technical authority for lab systems, the role sets technical direction and standards, owns the most complex solutions end to end, and mentors other IT staff in validated delivery practices. It reports to the Director of Information Systems.

Responsibilities

• Serve as the senior technical authority for bioanalytical laboratory systems, setting design, configuration, and integration standards and owning the technical roadmap for the lab application landscape.
• Gather, analyze, and document business, laboratory, and data requirements from the lab, and translate them into user requirement specifications, functional designs, and configuration specifications.
• Design, configure, develop, and deploy GxP solutions that support sample management, testing workflow management (LIMS), instrument integration, electronic records, and quality system management.
• Own the technical side of the system lifecycle, including environment build and configuration management, code and configuration version control, unit and integration testing, and writing and executing IQ/OQ/PQ test scripts.
• Produce technical validation documentation, including design specifications, configuration records, traceability, and test evidence, to the standard IT Compliance and Quality Assurance require for approval.
• Manage technical change controls and releases so changes are risk-assessed, tested, documented, and promoted only through approved, validated pathways.
• Lead end to end delivery of complex or multi-system initiatives, 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, performing root cause analysis, resolving defects, and escalating 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.
• Work with IT Compliance, Quality Assurance, and lab scientists to make sure delivered solutions are fit for purpose, inspection-ready, and maintained in a validated state.

Required Skills

• Bachelor's degree in Information Technology, Computer Science, Information Systems, Bioinformatics, or a related discipline, or an equivalent combination of education and experience.
• 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 writing specifications and executing IQ/OQ/PQ test scripts.
• Proven 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, with the 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 about when to configure, customize, adopt vendor functionality, or standardize, balancing validation burden against business need.
• Ability to make sound technical design decisions independently and justify them to compliance, Quality Assurance, and business stakeholders.

Bonus / Soft Skills

• IT experience in a high throughput clinical research organization (CRO), strongly preferred.
• Experience with bioanalytical workflows such as sample lifecycle, assay runs, chain of custody, and study data reporting, strongly preferred.
• Experience mentoring or providing technical review for other IT staff, strongly preferred.
• Provides day to day guidance and mentoring in a consistently supportive, collaborative way.
• Strong written and verbal communication, including explaining technical concepts and trade-offs to scientists, Quality Assurance, and non-technical stakeholders.
• Professional presence and strong interpersonal skills, working courteously, promptly, and diplomatically with all levels of the organization and with vendors.
• Strong attention to detail, critical thinking, and sound judgment on ambiguous, cross-functional technical problems with competing priorities.
• Continuous learning mindset, keeping up with laboratory informatics developments, vendor roadmaps, and evolving data integrity expectations.
• Works well independently or with cross-functional teams.

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