Senior Information Technology GxP Technical Analyst (GxP)

Location: Rockville, MD, United States; hybrid workplace

Annual base salary: $116,600–$177,800

Company

hirify.global develops and supports bioanalytical laboratory solutions and systems.

What you will do

• Act as the senior technical authority for Bioanalytical Laboratory systems, defining design, configuration, integration standards, and the technical roadmap.
• Translate laboratory and scientific workflows into requirements, functional designs, configuration specifications, and validated system behavior.
• Design, configure, develop, deploy, and support LIMS, sample management, instrument integrations, electronic records, and quality systems.
• Lead system lifecycle activities including environment configuration, version control, unit and integration testing, and IQ/OQ/PQ test execution.
• Manage technical change controls, releases, upgrades, patches, impact assessments, regression testing, and vendor coordination.
• Perform root cause analysis, resolve application and interface defects, and partner with scientists, Quality Assurance, IT Compliance, Cybersecurity, Enterprise Systems, and vendors.

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, including laboratory instrument or chromatography data system integration.
• Experience delivering solutions through a validated SDLC, including authoring specifications and executing IQ/OQ/PQ test scripts.
• Experience leading technical delivery of computerized system implementations or major upgrades, including vendor and stakeholder coordination.
• Advanced knowledge of GxP requirements, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.
• Technical skills in configuration, scripting, SQL, reporting tools, APIs, 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.
• Strong analytical, troubleshooting, documentation, communication, and autonomous technical decision-making skills, including the ability to explain trade-offs to scientists, Quality Assurance, and non-technical stakeholders.

Nice to have

• Experience in an IT role within a high-throughput clinical research organization or CRO.
• Experience with bioanalytical workflows including sample lifecycle, assay runs, chain of custody, and study data reporting.
• Experience mentoring or technically reviewing other IT staff.

Culture & Benefits

• Full-time hybrid position with collaborative work across laboratory, quality, compliance, cybersecurity, enterprise systems, and vendor teams.
• Medical, dental, vision, prescription, flexible spending, and company-paid disability insurance benefits.
• 401(k) plan with company matching, paid vacation, sick leave, holidays, and parental leave.
• Group life and accidental death and dismemberment insurance, employee assistance, and additional voluntary insurance and wellness benefits.
• Equal Opportunity/Affirmative Action employer; E-Verify is used to validate candidate work eligibility.