Foster City, CA2 days ago
Responsibilities:Provide operational and maintenance support for GxP and business applications, including incident resolution, access management, and job monitoring to ensure system reliabilityLead and execute validation activities (CSV lifecycle), including protocol authoring, review, execution, and audit readiness using ValGenesisManage quality events (Change Control, Deviations, CAPA) in Quality Management System to ensure compliance with GxP and regulatory requirementsPerform periodic maintenance activities for GxP and business systems, including SATR, server maintenance, backup/restore testing, and disaster recovery (DR) validationManage infrastructure lifecycle, including server upgrades, decommissioning, and cloud (AWS) resource optimizationDrive security and vulnerability management, ensuring timely patching and remediation across systemsSupport system migrations and enhancements, including data mapping, validation, and on-prem to cloud transitionsLead Agile/Scrum activities, including facilitating daily stand-ups, managing sprint tasks, and tracking team deliverables using tools such as JIRA/Azure DevOpsParticipate in SQA testing and continuous improvement initiatives to enhance system performance and efficiencyMaintain dashboards and reports to monitor system performance and provide actionable insightsConduct GxP system instructor-led training and engage stakeholders to ensure effective system usage, compliance, and adoptionCoordinate with cross-functional teams to prioritize work, manage dependencies, and drive operational excellence **Only those lawfully authorized to work in the designated country associated with the position will be considered.** Education:Bachelor’s degree in Computer Science, Information Technology, or related disciplineRequired Skills:8+ years of relevant experienceDemonstrated experience in GxP system administration and Computer System Validation (CSV)Expertise in Server and infrastructure management, including backup/restore and disaster recoveryExpertise in Cloud platforms (AWS/Azure) and enterprise IT environmentsHands-on experience with validation and quality systems (ValGenesis or equivalent, Veeva QMS)Proficiency with project and reporting tools, including Azure DevOps, JIRA, MS VisioPreferred Skills:Exposure to SAP ecosystemsExperience with automation and process optimization (RPA)Summary:This role is responsible for system administration, validation, and operational support within a life sciences environment to ensure compliant, reliable, and efficient systems.