Software Development Senior Specialist

LIMS developers

Job Summary
We are looking for a skilled LIMS Developer to design, develop, configure, and support Laboratory Information Management Systems (LIMS) used in regulated laboratory environments. The ideal candidate will have strong technical expertise in LIMS platforms, database development, and integrations, with a solid understanding of laboratory workflows and compliance requirements.

Key Responsibilities
LIMS Development & Configuration
Develop and configure LIMS applications to support laboratory workflows such as sample management, testing, results entry, approvals, stability, and reporting.
Customize LIMS using business rules, scripts, forms, workflows, and configurations.
Build and maintain custom reports, labels, and dashboards.
Technical Design & Enhancements
Translate functional requirements into technical designs and system configurations.
Implement system enhancements, change requests, and defect fixes.
Perform impact analysis for changes and upgrades.
Integration & Data Handling
Develop and support LIMS integrations with laboratory instruments, ERP systems (e.g., SAP), ELN, SDMS, MES, and external applications.
Design and execute data migration and data cleansing activities.
Ensure data accuracy, integrity, and traceability.
Validation & Compliance Support
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.
Production Support & Maintenance
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.