LIMS Configuration Analyst Labware

Job Description

Job Title

LabWare LIMS Configuration & Integration Specialist (LabWare 8)

Job Type

Contingent Worker

Location

US-Based Site (Onsite / Hybrid / remote as required)

Job Summary

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.

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
• 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.

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 requirements-to-configuration-to-validation 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.

Required Skills :

Basic Qualification :

Additional Skills :

Background Check : No

Drug Screen : No