Proven hands-on experience configuring LabWare LIMS, with LabWare 8 preferred.
Strong experience with LabWare in GMP laboratory operations, particularly in raw materials and commercial product testing.
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 like Empower and LabX.
Strong cross-functional communication skills in regulated environments.
Responsibilities
Lead a dedicated workstream for implementing raw material and commercial product processes in LabWare LIMS 8.
Define and manage LabWare build for raw materials, commercial products, and laboratory equipment.
Configure LabWare LIMS with standardized designs for raw materials, commercial products, and stability testing.
Ensure LabWare configurations align with approved test methodologies and product specifications.
Translate regulatory and quality requirements into LabWare LIMS designs.
Support validation activities with documentation and traceability for LabWare objects.
Configure and support instrument interfaces between LabWare 8 and various laboratory systems.
Benefits
Opportunity to play a key role in the LabWare 8 upgrade for a GMP lab.
Engage in close collaboration with multiple teams including Quality, Validation, IT, and Laboratory.
Potential for hands-on experience dealing with equipment integration and operational readiness.
Work in a regulated environment which can enhance professional credibility and expertise.
Full Job Description
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.
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:
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.
