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. Responsibilities include leading validation activities (authoring, execution, and review of protocols), project management and administering both GxP and business applications.

Responsibilities:

• 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 ValGenesis.
• 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 DevOps.
• 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.

Requirements:

• 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 (ValGenesis or equivalent, Veeva QMS).
• Proficiency with project and reporting tools, including Azure DevOps, JIRA, MS Visio.
• Exposure to SAP ecosystems.
• Experience with automation and process optimization (RPA).