Validation Engineer
Kodiak SciencesPalo Alto, California, United States
Posted March 20, 2026
Full Time
About the Company
Kodiak Sciences is a biopharmaceutical company dedicated to developing transformative therapeutics for high prevalence retinal diseases. Utilizing its innovative ABC Platform™, which merges antibody-based and chemistry-based therapies, Kodiak focuses on creating next-generation medicines like tarcocimab, KSI-501, and KSI-101 to address unmet needs in retinal vascular and inflammatory diseases. The company fosters a culture of curiosity, creativity, compassion, and courage, aiming to make a significant impact in the field of ophthalmic therapeutics.
Job Description
Kodiak Sciences is seeking a Validation Engineer to join its Digital Transformation Department, with a focus on validating cloud and custom systems for the biotechnology company.
Requirements
- 7+ years of Computerized System Validation (CSV) experience in biotech, pharma, or medical devices
- Strong expertise in validating cloud platforms (Azure, AWS), SaaS, and custom applications
- Deep knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5
- Proven ability to produce inspection-ready documentation and support FDA audits
- Strong communication skills; able to present to executive/C-level stakeholders
- Experience in clinical systems, CI/CD in regulated environments, and vendor/SOC 2 reviews (preferred)
