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Labware LIMS Configuration & Integration Specialist.

Katalyst Healthcares & Life Sciences

  • Thousand Oaks, CA
  • 30+ days ago

    Highlights

    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. Support validation activities by providing clear documentation and traceability for configured LabWare objects following Takeda internal procedures.

    Numbers & Facts

    LocationThousand Oaks, CA

    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:
    • 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.
    Required Qualifications with Integrating LabWare:
    • 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.
    • Instrument systems (e.g., Empower, LabX).
    • Strong cross functional communication skills in regulated environments.
    • 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.
    • Onsite presence may be required based on project phase and site needs.

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