Lab Ware LIMS Configuration & Integration Specialist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a 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

Qualifications

• Proven hands-on experience configuring LabWare LIMS (LabWare 8 strongly preferred).
• Experience in GMP lab operations with raw materials and commercial products.
• Ability to translate regulatory and quality requirements into compliant LIMS configurations.
• Experience supporting LIMS validation with full requirements traceability.
• Strong cross-functional communication in regulated environments.

Responsibilities

• Lead LabWare LIMS 8 configuration build for raw materials and products.
• Define and manage LabWare builds across master data and workflows.
• Configure instrument interfaces and data exchanges with GMP systems.
• Support validation via traceability documentation.
• Ensure operational readiness and issue troubleshooting in live ops.

Skills

LabWare LIMS

GMP operations

Configuration

Cross-functional comms

Tools

LabWare 8

LabX

Empower

Job description

• LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a USbased 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.

Job Description

• LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a USbased 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:

• 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

• Proven handson 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.

• Experience integrating LabWare with:

• Instrument systems (e.g., Empower, LabX)

• Strong crossfunctional communication skills in regulated environments.

Preferred Qualifications

• 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 requirementstoconfigurationtovalidation 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.