LIMS Administrator

Responsibilities Administer, configure, and maintain the LIMS platform, including user access, workflows, test methods, specifications, and instrument integrations Support day-to-day LIMS operations, including troubleshooting user issues, resolving system errors, and coordinating with IT/vendor support as needed Lead or support validation and qualification (IQ/OQ/PQ) activities for LIMS implementations, upgrades, and configuration changes in partnership with Validation and Quality teams Manage LIMS user access controls, roles, and permissions in compliance with data integrity and 21 CFR Part 11 requirements Support integration of LIMS with laboratory instruments, ERP, MES, and other quality/data systems Author and maintain LIMS configuration documentation, SOPs, and change control records Investigate and support root cause analysis for LIMS-related deviations, data discrepancies, or system downtime Serve as LIMS subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support Coordinate LIMS system upgrades, patches, and periodic review activities, ensuring minimal disruption to lab operations Partner with QC, QA, and R&D lab personnel to translate testing and workflow requirements into LIMS configuration Support training of end users on LIMS functionality, new features, and best practices Ensure LIMS design, configuration, and documentation comply with FDA regulations, cGMP, 21 CFR Part 11, and internal data integrity standards (ALCOA+) Support risk assessments (FMEA) for LIMS changes, upgrades, or new instrument/method integrations Maintain accurate, audit-ready documentation for all LIMS validation, configuration, and change control activities Qualifications Required: Bachelor's degree in Information Technology, Chemistry, Biology, Engineering, or related field 3+ years of experience administering or supporting a LIMS platform (e.g., LabWare, LabVantage, STARLIMS, Thermo SampleManager, or similar) in a pharmaceutical, biotech, or medical device environment Strong working knowledge of cGMP, FDA regulations, 21 CFR Part 11, and data integrity principles (ALCOA+) Experience supporting or leading validation activities (IQ/OQ/PQ) for computerized laboratory systems Familiarity with laboratory instrument integration and workflows (e.g., HPLC, GC, dissolution testing) Experience supporting or leading FDA/regulatory inspections as a LIMS SME Proficiency with MS Office and database/reporting tools; SQL knowledge a plus Strong written and verbal communication skills, with ability to support both technical and non-technical stakeholders Ability to work effectively in a cross-functional, highly regulated laboratory environment #J-18808-Ljbffr