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KH

LabWare LIMS Specialist

Katalyst Healthcares & Life Sciences
  • 🇺🇸 United States
  • On-site
  • 19 hours ago
  • GMP
19 hours ago
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Key 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:
  • Approved test methodologies
  • 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.
Must Haves:
  • 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.

LabWare LIMS Specialist · Katalyst Healthcares & Life Sciences

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