LabWare LIMS Specialist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO seeks an experienced LabWare LIMS configuration specialist to support a dedicated workstream for raw material and commercial product processes within LabWare LIMS 8. The role focuses on defining builds, master data, equipment interfaces, and ensuring compliant, scalable configurations in GMP laboratory environments.

Applicants should translate regulatory and quality requirements into LabWare designs, support validation activities with clear traceability, and coordinate with site

Qualifications

• 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.

Responsibilities

• Lead workstream scope and delivery for LabWare LIMS implementation.
• Define and manage LabWare build across raw materials and commercial product master data and equipment interfaces.
• Configure LabWare LIMS using standardized, compliant design patterns to ensure consistency and scalability.

Tools

LabWare LIMS

LabWare 8

Job description

• 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
• 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.

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.