Kyverna is seeking an experienced IT Validation Engineer to support the implementation, validation, and lifecycle management of computerized systems across GxP and regulated business functions. This role will play a critical hands-on role in executing Kyverna’s Computer Software Assurance (CSA) program, supporting system onboarding, validation deliverables, and vendor/system assessments to ensure compliance with regulatory requirements (e.g., FDA, EMA, 21 CFR Part 11). The ideal candidate thrives in a fast-paced environment, is comfortable owning execution, and can partner cross-functionally with IT, Quality, Clinical, and external vendors ensuring that GxP systems are validated, compliant, and inspection-ready.
Department: IT
Location: Remote eligible
Reports To: Associate Director, IT Compliance
Execute validation activities for GxP computerized systems using a risk-based Computer Software Assurance (CSA) approach.
Author and maintain validation deliverables, including Validation Plans, Risk Assessments, Test Scripts and Protocols, and Validation Summary Reports.
Support full system lifecycle activities, including implementation, change control, periodic review, and system retirement.
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, evaluating the impact of system changes and enhancements on validated state.
Serve as the validation lead for key GxP platforms, including Veeva Vault (eQMS, QualityDocs, Training) and other regulated systems.
Ensure systems remain in a validated state in compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles, including ALCOA+.
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, including direct interaction with agencies such as the U.S. Food and Drug Administration and European Medicines Agency.
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.
Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or a related discipline.
A minimum of 6 years of experience in IT validation, Computer System Validation (CSV), or GxP-regulated systems within biotechnology, pharmaceutical, or similarly regulated environments.
Demonstrated hands-on expertise in CSV methodologies, including execution of IQ, OQ, PQ, and UAT activities.
Strong working knowledge of Computer Software Assurance (CSA) principles, 21 CFR Part 11 and broader GxP regulatory requirements, and data integrity standards, including ALCOA+.
Proven ability to independently author and manage validation documentation across the full system lifecycle, from planning through execution and final reporting.
Experience with eQMS, document management systems, and/or clinical systems is preferred.
Direct experience supporting or owning validation activities for GxP systems such as Veeva Vault, eQMS platforms, or comparable regulated applications.
Experience performing supplier system assessments and managing vendor-provided validation documentation.
Strong cross-functional collaboration skills, with a demonstrated ability to partner effectively with Quality, IT, and business stakeholders.
High level of attention to detail, with a focus on documentation accuracy and inspection readiness.
Ability to operate with a high degree of ownership, accountability, and autonomy in a fast-paced, regulated environment.
Gillig
Axon
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