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.
- 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.
- Experience integrating LabWare with:
- Instrument systems (e.g., Empower, LabX)
- Strong cross‑functional communication skills in regulated environments.
Preferred Qualifications:
- 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
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
- 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.