Valgenesis system support engineer

About the Role

We are seeking a Valgenesis System Support Engineer to join or continue in Westbourne Lab IT services at the client site. The engineer will provide troubleshooting and support to Valgenesis users at GQCS in Foster City and Edmonton, as well as perform system administration activities required by the system owner. The role involves ensuring optimal system performance, assisting users with system-related issues, and collaborating with cross-functional teams to implement enhancements and updates while adhering to GAMP standards in compliance with FDA 21CFR Part 11 and EU Annex 11.

Responsibilities

• Provide first- and second-level technical support to ValGenesis users, addressing system issues, errors, and user inquiries in a timely manner.
• Troubleshoot and resolve system-related problems, including configuration, integration, and performance issues.
• Log, track, and manage support tickets using a ticketing system, ensuring proper documentation and resolution.
• Perform routine system maintenance, including monitoring system performance, applying patches, and upgrading software as needed.
• Ensure system availability, reliability, and security by proactively identifying and addressing potential issues.
• Collaborate with IT and infrastructure teams to maintain server environments and database integrity.
• Assist in developing and delivering training sessions for end-users to ensure effective utilization of the ValGenesis system.
• Create and maintain user guides, FAQs, and technical documentation to support system users.
• Provide ongoing support to users, including answering questions and offering best practices for system usage.
• Ensure the ValGenesis system complies with regulatory standards (e.g., FDA, EMA, GxP) and internal quality policies.
• Support validation activities, including drafting and executing validation protocols (IQ/OQ/PQ) and maintaining validation documentation.
• Assist in audits and inspections by providing system-related documentation and evidence.
• Provide a monthly one-page slide report of activities, including training status, operational activities, project activities, and meeting schedules.
• Engage in monthly one-on-one meetings with the Westbourne manager.
• Attend the client site on a full-time or hybrid basis, as required.
• Engage professionally with client management, other teams at the client site, and Westbourne teams with a customer service mindset.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.
• 2+ years of experience in system support, preferably with ValGenesis or similar validation lifecycle management systems.
• Strong understanding of GxP regulations, validation principles, and compliance requirements in regulated industries.
• Proficiency in troubleshooting software applications, databases (e.g., SQL), and system integrations.