Job Overview
Location
Remote
Job Type
Full-time
Category
Engineering
Date Posted
April 23, 2026
Full Job Description
đź“‹ Description
- • Kyverna Therapeutics is seeking an experienced IT Validation Engineer to support the implementation, validation, and lifecycle management of computerized systems across GxP and regulated business functions, playing a critical role in executing the company’s Computer Software Assurance (CSA) program.
- • Day-to-day responsibilities include supporting system onboarding, preparing validation deliverables, conducting vendor and system assessments, and ensuring compliance with regulatory requirements such as FDA, EMA, and 21 CFR Part 11.
- • The role involves close collaboration with IT, Quality, Clinical, and external vendors to ensure GxP systems are validated, compliant, and inspection-ready in a fast-paced, mission-driven biopharmaceutical environment.
- • The successful candidate will gain hands-on experience in CSA methodologies, regulatory compliance for computerized systems, and cross-functional project execution within a clinical-stage cell therapy company at the forefront of autoimmune disease innovation.
🎯 Requirements
- • Bachelor’s degree in a relevant field such as Computer Science, Engineering, Life Sciences, or Information Technology.
- • Proven experience in IT validation, Computer Software Assurance (CSA), or GxP system validation within regulated industries (e.g., pharmaceutical, biotech, medical device).
- • Strong understanding of FDA regulations, 21 CFR Part 11, EMA guidelines, and GAMP principles.
- • Experience with validation lifecycle activities including IQ/OQ/PQ, risk assessments, traceability matrices, and validation documentation.
- • Ability to work independently and manage multiple priorities in a remote, fast-paced environment.
- • Excellent communication and collaboration skills for partnering with IT, Quality, Clinical, and external vendors.
🏖️ Benefits
- • Fully remote work eligibility, offering flexibility and work-life balance.
- • Opportunity to contribute to innovative cell therapies targeting autoimmune diseases with real patient impact.
- • Exposure to cutting-edge CSA practices and regulatory compliance in a growing clinical-stage biopharmaceutical company.
- • Professional development opportunities within a values-driven culture emphasizing clarity, collaboration, and innovation.
- • Competitive compensation and benefits package aligned with industry standards for regulated IT roles.
Skills & Technologies
About Kyverna Therapeutics, Inc.
Kyverna Therapeutics is a clinical-stage cell-therapy company developing engineered Treg and CAR-T cell treatments for autoimmune diseases. It combines synthetic biology with cellular engineering to create next-generation regulatory T cells that selectively suppress pathologic immune activity. Its lead candidate, KYV-101, is an autologous CD19 CAR-Treg therapy in Phase 1/2 trials for lupus nephritis and systemic sclerosis. Headquartered in Emeryville, California, Kyverna operates a cGMP manufacturing facility and is advancing a pipeline of programmable cell therapies aimed at resetting immune tolerance in chronic inflammatory disorders.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
5 days ago