Lab Ware LIMS Configuration & Integration Specialist
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2026-07-29
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-07-29
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Production QC/QA, Regulatory Compliance Specialist
Job Description & How to Apply Below
- Lab Ware LIMS Configuration Specialist to support the Lab Ware 8 upgrade for a USbased 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 Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
- Lab Ware LIMS Configuration Specialist to support the Lab Ware 8 upgrade for a USbased 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 Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
- Workstream Leadership & Scope Definition
- Support a dedicated workstream supporting implementation of raw material and commercial product processes within Lab Ware LIMS 8.
- Define and manage Lab Ware build across:
- Raw materials and commercial product master data.
- Test workflows.
- Laboratory equipment and interfaces.
- Lab Ware LIMS Configuration
- Configure raw materials, commercial products including stability, and laboratory equipment in Lab Ware LIMS using standardized, compliant design patterns.
- Ensure Lab Ware configuration aligns with:
- Approved test methodologies.
- Product specifications.
- Sampling plans.
- Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
- Translate regulatory, quality, and operational requirements into standardized Lab Ware LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following Takeda internal procedures.
- Configure and support instrument interfaces between Lab Ware 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 Lab Ware and other GMP systems, such as LabX
- 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 Lab Ware configurations are fit for intended use and operationally sustainable.
- Proven handson experience configuring Lab Ware LIMS (Lab Ware 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 Lab Ware with:
- Instrument systems (e.g., Empower, LabX)
- Strong cross functional communication skills in regulated environments.
- Experience supporting Lab Ware upgrades or major LIMS implementations.
- Experience working in biopharmaceutical or pharmaceutical GMP environments.
- Experience supporting inspection readiness activities related to LIMS.
- Completed on time Lab Ware LIMS configurations for raw materials, commercial products, and equipment integration.
- Clear requirementstoconfigurationtovalidation traceability.
- Stable, compliant execution of configured workflows in operations.
- Successful integration between Lab Ware and laboratory instruments
- 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.
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