PROGRAM DESCRIPTION The Enterprise IT (EIT) Directorate oversees the strategic vision and implementation plan for IT systems and solutions for the enterprise at Leidos Biomedical Research, providing operational information and data systems support to Frederick National Laboratory for Cancer Research. KEY ROLES/RESPONSIBILITIES Provide operational support and sustainment for LIMS platforms supporting laboratory and research workflows Administer user accounts, roles, and permissions (RBAC) in compliance with NIH/NCI security policies and 21 CFR Part 11 Deliver Tier 2/3 troubleshooting and incident resolution; perform root cause analysis (RCA) and implement corrective and preventive actions (CAPA) Configure and maintain LIMS components including workflows, forms, master data, and business rules Support organoid and biospecimen lifecycle tracking, including derivation, passage history, cryostorage, and assay linkage Develop and maintain SQL queries, scripts, reports, and dashboards to support QC, traceability, and research data analysis Perform system maintenance, upgrades, and performance tuning in validated environments (Oracle/SQL Server) Execute change management and configuration control processes in accordance with GxP and SDLC requirements Support Computer System Validation (CSV) activities including IQ/OQ/PQ, validation documentation, and audit readiness Design and optimize workflow management to improve standardization and reproducibility of laboratory processes Develop and support system integrations (REST APIs, ETL) with laboratory instruments, ELN systems, and bioinformatics pipelines BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of bachelor’s degree in Biotechnology, Information Systems, Life Sciences, or related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency In addition to the education requirement, a minimum of two (2) years of progressively responsible experience supporting or administering LIMS or laboratory informatics systems Experience working in regulated environments (GxP, 21 CFR Part 11) Experience with SQL and relational databases (Oracle, SQL Server, or equivalent) Experience with application troubleshooting, system integration, and operational support Familiarity with SDLC, change control, and configuration management processes Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Experience with LabWare, LabVantage, STARLIMS, or similar platforms Experience supporting biospecimen management, organoid models, or high-throughput laboratory workflows Knowledge of NIH/NCI or federally funded research environments (FFRDC) Experience with CSV (IQ/OQ/PQ) and audit support Familiarity with ELN systems, bioinformatics pipelines, or scientific data platforms Experience with cloud or hybrid environments (AWS/Azure)