CSV Analyst

Job Description:

This role is responsible for system administration, validation, and operational support within a life sciences environment to ensure compliant, reliable, and efficient systems.

• Provide operational and maintenance support for GxP and business applications, including incident resolution, access management, and job monitoring to ensure system reliability.
• Lead and execute validation activities (CSV lifecycle), including protocol authoring, review, execution, and audit readiness using Val Genesis.
• Manage quality events (Change Control, Deviations, CAPA) in Quality Management System to ensure compliance with GxP and regulatory requirements.
• Perform periodic maintenance activities for GxP and business systems, including SATR, server maintenance, backup/restore testing, and disaster recovery (DR) validation.
• Manage infrastructure lifecycle, including server upgrades, decommissioning, and cloud (AWS) resource optimization.
• Drive security and vulnerability management, ensuring timely patching and remediation across systems.
• Support system migrations and enhancements, including data mapping, validation, and on-prem to cloud transitions.
• Lead Agile/Scrum activities, including facilitating daily stand-ups, managing sprint tasks, and tracking team deliverables using tools such as JIRA/Azure Dev Ops.
• Participate in SQA testing and continuous improvement initiatives to enhance system performance and efficiency.
• Maintain dashboards and reports to monitor system performance and provide actionable insights.
• Conduct GxP system instructor‑led training and engage stakeholders to ensure effective system usage, compliance, and adoption.
• Coordinate with cross‑functional teams to prioritize work, manage dependencies, and drive operational excellence.

• Bachelor's degree in Computer Science, Information Technology, or related discipline.
• 8+ years of relevant experience.
• Demonstrated experience in GxP system administration and Computer System Validation (CSV).
• Expertise in Server and infrastructure management, including backup/restore and disaster recovery.
• Expertise in Cloud platforms (AWS/Azure) and enterprise IT environments.
• Hands‑on experience with validation and quality systems (Val Genesis or equivalent, Veeva QMS).
• Proficiency with project and reporting tools, including Azure Dev Ops, JIRA, MS Visio.
• Exposure to SAP ecosystems.
• Experience with automation and process optimization (RPA).