Labware LIMS Configuration & Integration Specialist

Responsibilities

• 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.
• 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, 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 Takeda internal procedures.
• Instrument & System Integration
• 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
• 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.

Requirements

• Proven hands on experience configuring LabWare LIMS (LabWare 8 strongly preferred).
• Strong experience with Labware within GMP laboratory operations, particularly: Raw materials testing, Commercial product testing, Laboratory equipment workflows.
• Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations.
• Experience supporting LIMS validation with full requirements traceability.
• Instrument systems (e.g., Empower, LabX).
• Strong cross functional communication skills in regulated environments.
• Experience supporting LabWare upgrades or major LIMS implementations.
• Experience working in biopharmaceutical or pharmaceutical GMP environments.
• Experience supporting inspection readiness activities related to LIMS.

Qualifications

• Required Qualifications
• Proven hands on experience configuring LabWare LIMS (LabWare 8 strongly preferred).
• Strong experience with Labware within GMP laboratory operations, particularly: Raw materials testing, Commercial product testing, Laboratory equipment workflows.
• Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations.
• Experience supporting LIMS validation with full requirements traceability.
• Instrument systems (e.g., Empower, LabX).
• Strong cross functional communication skills in regulated environments.
• Experience supporting LabWare upgrades or major LIMS implementations.
• Experience working in biopharmaceutical or pharmaceutical GMP environments.
• Experience supporting inspection readiness activities related to LIMS.