5-7 years of hands-on experience with LabWare LIMS, especially LabWare 8.
Strong background in GMP laboratory operations and workflows.
Skilled in compliance with regulatory and quality requirements for LIMS configurations.
Experience with supporting LIMS validation and traceability of requirements.
Familiarity with integrating laboratory systems (e.g., Empower, LabX).
Proven communication skills within cross-functional teams in regulated settings.
Previous involvement in LIMS upgrades or significant implementations.
Responsibilities
Lead a workstream for the LabWare 8 upgrade implementation.
Define scope and manage LabWare build for raw materials and product processes.
Configure raw materials and commercial products within LabWare LIMS.
Test and verify workflows and instrument interfaces.
Ensure configurations align with approved test methodologies and product specifications.
Support operational readiness and troubleshooting during live operations.
Collaborate with site teams to ensure sustainable LIMS configurations.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work in a GMP-compliant laboratory setting.
Involvement in impactful LIMS projects and upgrades.
Chance to refine skills in regulatory compliance and validation support.
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.
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.
