Labware LIMS Configuration & Integration Specialist

Katalyst Talent Agency
Boston, MA, United States
2 months ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Job source

Tech stack

Software Design Patterns Laboratory Information Management Systems Requirements Traceability Data Streaming Systems Integration Data Management GXP

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.

Requirements

Do you have experience in Systems integration?, * 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.

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