Senior Analyst - II
ICONMA
Senior Analyst – II
Our client, a Biopharmaceutical company, is looking for a Senior Analyst – II for their Foster City, CA/Hybrid location.
Responsibilities:
- 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.
- 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)
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Vacancy posted 2 days ago
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