Job Summary (List Format) for LabWare LIMS Configuration & Integration Specialist (LabWare 8):
- Lead a dedicated workstream for LabWare 8 upgrade at a US-based GMP laboratory site.
- Implement and configure raw material and commercial product workflows in LabWare LIMS.
- Complete master data configuration for raw materials, commercial products, and laboratory equipment.
- Finalize and support integration between LabWare LIMS and laboratory equipment/enterprise GMP systems.
- Translate regulatory, quality, and operational requirements into standardized, compliant LabWare LIMS designs.
- Ensure stable and compliant execution of configured workflows in a regulated manufacturing environment.
- Define and manage LabWare builds, including test workflows, equipment, and interface management.
- Apply controlled build practices and normalized templates to maintain consistency, scalability, and compliance.
- Support validation activities, providing clear documentation and traceability for all LabWare configurations.
- Configure and support instrument interfaces and data flow between LabWare 8 and other GMP systems (e.g., LabX).
- Troubleshoot configuration and integration issues impacting laboratory operations.
- Collaborate with site teams to ensure LabWare configurations are operationally sustainable and fit for purpose.
- Deliver completed, validated LIMS configurations on time, with clear traceability from requirements to execution.
- Maintain close collaboration with Quality, Validation, IT, and Laboratory teams, adhering to Takeda’s change control and validation standards.
- Onsite presence may be required depending on project phase and site needs.