IT Validation Engineer

Kyverna Therapeutics is a patient-centered biopharmaceutical company seeking an IT Validation Engineer to support the implementation, validation, and lifecycle management of computerized systems across GxP and regulated business functions.

Requirements

• Execute validation activities for GxP computerized systems using a risk-based Computer Software Assurance (CSA) approach
• Author and maintain validation deliverables
• Support full system lifecycle activities
• Ensure all validation documentation is inspection-ready and aligned with internal procedures and global regulatory requirements
• Partner with IT and business stakeholders to support onboarding and implementation of new systems
• Provide validation guidance during system selection, configuration, and release to ensure compliance and scalability
• Participate in change control assessments
• Serve as the validation lead for key GxP platforms
• Ensure systems remain in a validated state in compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles
• Collaborate with IT and system owners to support system enhancements, releases, and ongoing periodic reviews
• Support IT due diligence and qualification of third-party vendors and supplier systems used in GxP environments
• Assess supplier validation packages, documentation, and control frameworks to ensure compliance with internal and regulatory standards
• Partner with Quality to evaluate risks, define mitigation strategies, and maintain effective supplier oversight
• Maintain continuous inspection readiness by ensuring completeness and accuracy of validation documentation, audit trails, and supporting artifacts
• Support internal audits, mock inspections, and regulatory inspections
• Proactively identify compliance gaps and drive remediation efforts to strengthen the overall validation and quality posture
• Act as the primary IT partner to Quality for validation, compliance, and data integrity-related activities
• Collaborate cross-functionally with Quality Systems, Clinical QA, Regulatory, and other GxP functions to align on validation strategy, risk management, and governance
• Support the development and continuous improvement of validation procedures, templates, and processes
• Provide training and guidance to system owners and stakeholders on validation requirements and best practices

Benefits

• Generous Paid Time Off
• 401k Matching
• Tuition Reimbursement
• Bonus
• Participation in Company’s stock plan