LabWare LIMS Configuration Specialist
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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., 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.
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 is required. (LabWare 8 strongly preferred). Strong experience with Labware within GMP laboratory operations is required, particularly:
- Raw materials testing
- Commercial product testing
- Laboratory equipment workflows
Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations is required. Experience supporting LIMS validation with full requirements traceability is required. Experience integrating LabWare with instrument systems is required. Prefer experience with Empower and LabX.
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.