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The LIMS Developer will design, develop, and support Laboratory Information Management Systems in regulated environments. Candidates should have expertise in LIMS platforms, database development, and compliance. Responsibilities include developing LIMS applications, supporting integrations, and ensuring data accuracy. A minimum of 5 years of experience is required, with a focus on compliance and laboratory workflows.
Job Responsibility:
Develop and configure LIMS applications to support laboratory workflows
Customize LIMS using business rules, scripts, forms, workflows, and configurations
Build and maintain custom reports, labels, and dashboards
Translate functional requirements into technical designs and system configurations
Implement system enhancements, change requests, and defect fixes
Perform impact analysis for changes and upgrades
Develop and support LIMS integrations with laboratory instruments, ERP systems, ELN, SDMS, MES, and external applications
Design and execute data migration and data cleansing activities
Ensure data accuracy, integrity, and traceability
Support Computer System Validation (CSV) activities
Develop and execute IQ/OQ/PQ scripts, test cases, and validation documentation
Ensure compliance with GxP, FDA 21 CFR Part 11, ISO 17025, GLP, GMP requirements
Provide L2/L3 production support for LIMS applications
Troubleshoot system issues, perform root cause analysis, and implement corrective actions
Monitor system performance and support upgrades and patches