Job Description:
• LabWare LIMS Configuration Specialist to support the LabWare 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 LabWare LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
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.
Lab Ware LIMS Configuration:
• Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
Ensure LabWare configuration aligns with:
• pproved test methodologies.
• Product specifications.
• Sampling plans.
• pply 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.
Required Qualifications with Integrating LabWare:
• 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.
• Deliverables & Success Criteria.
• Completed on time LabWare 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 LabWare and laboratory instruments.
Additional Notes:
• 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.