LIMS Specialist

Responsible for configuring, maintaining, and supporting Laboratory Information Management Systems (LIMS) to streamline laboratory workflows, sample management, testing, and data reporting. Ensures system performance, data integrity, and regulatory compliance with cGMP, GLP, and FDA requirements. Supports system validation, troubleshooting, user training, documentation, and continuous improvement of laboratory processes.

• Bachelor's degree in Computer Science, Information Technology, Life Sciences, Chemistry, Biotechnology, or a related field.
• 2-5 years of experience in LIMS administration, configuration, implementation, or support.
• Experience with LIMS platforms such as LabWare, LabVantage, Thermo Scientific SampleManager, or STARLIMS.
• Knowledge of laboratory workflows, sample management, testing, and results reporting.
• Experience with system configuration, troubleshooting, user support, and workflow optimization.
• Knowledge of SQL, databases, and data management.
• Understanding of cGMP, GLP, FDA regulations, and laboratory compliance requirements.
• Experience with Computer System Validation (CSV), including IQ/OQ/PQ, test scripts, and validation documentation.
• Knowledge of data integrity principles, including ALCOA+.
• Experience preparing SOPs, technical documentation, and system change-control records.
• Strong analytical, communication, problem-solving, and cross-functional collaboration skills.
• Workstream Leadership & Scope Definition
• Support a dedicated workstream supporting implementation of raw material and commercial product processes within LabWare LIMS 8.
• Define and manage LabWare build across:
• Raw materials and commercial product master data
• Test workflows
• Laboratory equipment and interfaces
• LabWare LIMS Configuration to Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns. Ensure LabWare configuration aligns with Approved test methodologies, Product specifications and Sampling plans
• Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
• Requirements Traceability & Validation Support
• Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
• Support validation activities by providing clear documentation and traceability for configured LabWare objects following Client internal procedures.
• Instrument & System Integration to Configure and support instrument interfaces between LabWare 8 and a variety of laboratory systems.
• May develop or support parsing scripts, where required and permitted by Takeda standards and governance.
• Support connectivity and data flow between LabWare and other GMP systems, such as LabX
• Operational Readiness & Execution to Support stable execution of raw material and equipment workflows in live operations.
• Troubleshoot configuration and integration issues impacting laboratory execution.
• Partner with site teams to ensure LabWare configurations are fit for intended use and operationally sustainable.