Labware LIMS Configuration & Integration Specialist

Overview

Job Description: Lab Ware LIMS Configuration Specialist to support the Lab Ware 8 upgrade for a US based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product workflows, completing master data configuration, and finalizing integration with laboratory equipment and enterprise GMP systems. The successful candidate will translate regulatory, quality, and operational requirements into standardized, compliant Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.

• Workstream Leadership & Scope Definition.
• Support a dedicated workstream supporting implementation of raw material and commercial product processes within Lab Ware LIMS 8.
• Define and manage Lab Ware 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 Lab Ware LIMS using standardized, compliant design patterns.

• Approved test methodologies.
• Product specifications.
• Sampling plans.
• Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.

• Translate regulatory, quality, and operational requirements into standardized Lab Ware LIMS designs.
• Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following Takeda internal procedures.

• Configure and support instrument interfaces between Lab Ware 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 Lab Ware and other GMP systems, such as LabX.

• 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 Lab Ware configurations are fit for intended use and operationally sustainable.

• Proven hands on experience configuring Lab Ware LIMS (Lab Ware 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 Lab Ware upgrades or major LIMS implementations.
• Experience working in biopharmaceutical or pharmaceutical GMP environments.
• Experience supporting inspection readiness activities related to LIMS.
• Deliverables & Success Criteria.
• Completed on time Lab Ware LIMS configurations for raw materials, commercial products, and equipment integration.
• Clear requirements to configuration to validation traceability.
• Stable, compliant execution of configured workflows in operations.
• Successful integration between Lab Ware and laboratory instruments.

• This role requires close collaboration with Takeda Quality, Validation, IT, and Laboratory teams.
• Work must follow Takeda change control, validation, and data integrity requirements.
• Onsite presence may be required based on project phase and site needs.