Sr. IT Quality Engineering Specialist
Core
Technical lead for the Kite Laboratory Information Management System (KLIMS) ensuring operational stability, compliance, and maintenance of the LabVantage platform for North American West Coast laboratory operations.
Role type
Senior IT Quality Engineering Specialist (LIMS Technical Lead)
Builds
Reliable and compliant laboratory operations for personalized CAR T-cell therapy development
Domain
Biopharmaceutical / Cell Therapy / Regulated GxP Environment
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
LIMS administration (LabVantage), GxP compliance, SQL, Java, root cause analysis, validation documentation, change management, incident response, system patching, stakeholder engagement
Preferred skills
Laboratory instrument integrations, barcode technologies (BarTender, Zebra), cloud-hosted infrastructure, pharmaceutical operations experience, audit participation
Technologies
LabVantage, SQL, Java, BarTender, Zebra printers
Responsibilities
Provide day-to-day administration and troubleshooting for KLIMS; Act as North America technical lead for system strategy and enhancements; Execute application patching, upgrades, and routine maintenance; Support validation activities and ensure GxP/CSV compliance; Manage technical documentation and knowledge articles; Coordinate interface qualification for laboratory instruments; Partner with QC, Manufacturing, and Validation teams to resolve technical issues and support audits.
Seniority
Senior, hands-on IC with technical leadership
