Valgenesis system support engineer

Job Title

Valgenesis system support engineer

Requirement

The Valgenesis engineer to join or continue in Westbourne Lab IT services at the client site. The engineer will have experience of troubleshooting and providing support to Valgenesis users at GQCS at Foster City and Edmonton. The engineer will also support system administration activities required by system owner. The role involves ensuring the system's optimal performance, assisting users with system-related issues, and collaborating with cross-functional teams to implement system enhancements and updates. Engineer will act in accordance with GAMP standards in compliance with FDA 21CFR Part 11 and EU Annex 11.

Technical 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.

System Maintenance:

·        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.

User Training and Documentation:

·        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.

Compliance and Validation Support:

·        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.

Managed Service and client relationship

Provide monthly 1 page slide report of activities of training status, operation activities, project activities and meeting schedule.

Engage with and attend monthly one on one with Westbourne manager.

Attend client site on fulltime or hybrid basis, based on client and Westbourne requirements and as instructed by Westbourne manager.

Engage with client management, other teams at client site and Westbourne teams in a professional manner and with a customer service mindset.

Education and required Experience

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.