LIMS Specialist

Katalyst-Healthcares-; Thousand Oaks (CA); On-site; USD 85,000 - 140,000; Full time

Job summary

Katalyst-Healthcares- is seeking a LabWare LIMS specialist to support the implementation and configuration of raw material and commercial product processes within LabWare LIMS 8. You will lead workstreams, ensure compliant designs, and collaborate with site teams to maintain operational readiness.

Responsibilities include configuring materials, products, stability, equipment, and interfaces, plus supporting validation activities and data flow between systems.

Responsibilities

• Lead workstream leadership and scope definition.
• Support implementation of raw material and commercial product processes within LabWare LIMS 8.
• Define and manage LabWare build across raw materials and commercial products, including test workflows.
• Configure LabWare for raw materials and commercial products including stability and laboratory equipment.
• Configure LabWare LIMS using standardized, compliant design patterns and align with approved test methodologies.
• Apply controlled build practices and normalized templates to ensure consistency, scalability and compliance.
• Support regulatory, quality, and operational requirements translation into LabWare designs.
• Assist validation activities with documentation and traceability for LabWare objects.
• Configure instrument interfaces between LabWare 8 and other laboratory systems.
• May develop or support parsing scripts as per Takeda standards and governance.
• Facilitate connectivity and data flow between LabWare and 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.
• Collaborate with site teams to ensure LabWare configurations are fit for intended use and sustainable.

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 to 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 and 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 Client internal procedures.
• Instrument & System Integration to 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 to 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.