LabWare LIMS Specialist

Katalyst-Healthcares-; Thousand Oaks (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Takeda is seeking a LabWare LIMS configuration specialist to lead a workstream implementing LabWare 8 for raw materials and commercial product processes. You will define scope, configure master data, and ensure alignment with validated methodologies and GMP requirements.

Responsibilities include configuring LabWare interfaces to instruments and GMP systems, supporting validation, and ensuring operational readiness in live lab environments.

Qualifications

• Hands-on LabWare LIMS configuration experience, LabWare 8 preferred.
• Experience in GMP laboratory operations with raw materials and product testing.
• Ability to translate regulatory and quality requirements into compliant LIMS configurations.
• Experience configuring instrument interfaces and data flows between LabWare and GMP systems.

Responsibilities

• Lead workstreams defining scope for LabWare LIMS implementation.
• Configure LabWare 8 for raw materials and commercial product master data.
• Configure raw materials, commercial products, stability, and lab equipment in LabWare using standardized patterns.
• Ensure LabWare configuration aligns with approved test methodologies and compliance.
• Support validation activities with traceability documentation.
• Configure instrument interfaces between LabWare 8 and other GMP systems; support parsing scripts.
• Ensure operational readiness and troubleshoot live lab operations.

Skills

LabWare LIMS configuration

GMP laboratory operations

Raw materials testing

Commercial product testing

Laboratory equipment workflows

Translate regulatory requirements

Job description

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.