Computer System Validation

Job Title: Sr. Analyst - II/CSV Analyst

Location: Foster City CA

Duration: 06 Months

Hybrid Position - Foster City - Local Candidates

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.

Key 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

Qualifications & Experience

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

Nice to Have

Exposure to SAP ecosystems

Experience with automation and process optimization (RPA)