Sr. IT Quality Engineering Specialist
Gilead Sciences•El Segundo, CA
•$115,260 - $149,160•Onsite
About The Position
The Senior IT Quality Engineering Specialist serves as the technical lead for the Kite Laboratory Information Management System (KLIMS) within North America West Coast (El Segundo). This role is responsible for the operational stability, compliance, maintenance, enhancement, and technical governance of the LabVantage platform and associated integrations. The position partners closely with Quality Control, Manufacturing, Validation, Infrastructure, and Kite Business stakeholders to ensure reliable and compliant laboratory operations.
Requirements
- Bachelor's degree in Information Technology, Computer Science, Engineering, or related field with 5+ years of experience.
- Experience supporting regulated GxP applications.
- Experience administering Laboratory Information Management Systems (LIMS), mandatory LabVantage.
- Strong troubleshooting and root cause analysis skills.
- Strong documentation and validation experience.
- Experience with SQL and database querying with Java.
- Knowledge of change management, validation, and compliance processes.
- Experience supporting enterprise applications in a production environment.
Nice To Haves
- Experience with laboratory instrument integrations.
- Knowledge of BarTender, Zebra printers, and barcode technologies.
- Experience supporting cloud-hosted or enterprise infrastructure environments.
- Familiarity with pharmaceutical, biotechnology, or cell therapy operations.
- Experience participating in audits, inspections, and regulated validation activities.
Responsibilities
- Provide day-to-day administration and technical support for KLIMS and related systems.
- Work with local Kite SMEs to prioritize roadmap initiatives with significant benefit to site operations.
- Deliver immediate troubleshooting for issues/incidents experienced at the site.
- Improve change management at the site level by communicating new Global functions being implemented that impact the site.
- Provide hands-on training when needed to local QC personnel.
- Sit on site tech councils to represent KLIMS initiatives and assess system impact by initiatives outside of the QC organization.
- Monitor system health, performance, and operational stability.
- Perform break-fix investigations and resolution activities.
- Support 24x7 incident response and escalation processes.
- Maintain technical documentation, knowledge articles, and support procedures.
- Support business continuity, disaster recovery, and system resilience initiatives.
- Act as a North America technical lead for KLIMS.
- Provide technical strategy and guidance for system enhancements, upgrades, and sustainment activities.
- Perform technical impact assessments for proposed changes.
- Review technical solutions, configurations, and code changes.
- Partner with global technical leads to ensure alignment of standards and best practices.
- Execute application patching, upgrades, and routine maintenance activities.
- Support validation activities and infrastructure qualification efforts.
- Ensure compliance with GxP, CSV, and internal quality procedures.
- Maintain CMDB records, system inventories, and controlled documentation.
- Support audits, inspections, investigations, CAPAs, and deviation resolution activities.
- Participate in project planning and technical scoping activities.
- Identify and manage technical deliverables for system projects.
- Support deployment of new functionality, integrations, and site rollouts.
- Collaborate with project managers, business analysts, developers, and validation resources to deliver compliant solutions.
- Provide hypercare and post-deployment support for new releases.
- Support laboratory instrument interfaces and integration troubleshooting.
- Investigate hardware, operating system, network, security, and interface-related issues.
- Coordinate interface qualification and requalification activities.
- Support barcode scanners, Zebra printers, SSL certificates, and related technical infrastructure.
- Partner with QC, Manufacturing, Validation, and IT teams to resolve technical issues.
- Provide technical training and knowledge transfer to users and support personnel.
- Communicate system status, risks, and project progress to stakeholders.
- Serve as an escalation point for complex technical issues.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
