System Administration & Operational Support
• 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.
Platform Maintenance & Compliance
• 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.
Project Delivery & Enhancements
• 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.
Instrument & Integration Support
• 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.