Title: LabWare LIMS Validation Specialist
Location: Thousand Oaks, CA 91320 (Hybrid)
Duration: 9+ Months (Possible extension)
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 specification
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
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
Benefits:
We offer a competitive compensation package that includes:
• Pay Rate: $85 - $95 per Hour
o Note: Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.