Labware LIMS Specialist

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.

Required 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

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 cross functional communication skills in regulated environments.