Validation Engineer

Job description

Kodiak Sciences is a fast-growing clinical-stage biotechnology company with a strong focus in ophthalmology. Our Antibody Biopolymer Conjugate Drug (ABCD) platform merges the fields of protein engineering, organic chemistry, and polymer chemistry and is at the core of our discovery engine. We are seeking a highly skilled and motivated Validation Engineer to join our Digital Transformation Department. The ideal candidate will be passionate, ready to manage several projects simultaneously, and have excellent writing and communication skills. The candidate will leverage state of the art technologies to improve the efficiencies of workflows and system maintenance and stay up to date with the latest FDA regulations and methodology. The candidate is expected to drive a variety of projects rapidly and simultaneously while communicating updates clearly and effectively to management. Key Responsibilities - Lead end-to-end validation of GxP cloud and custom systems (Azure, AWS, SaaS/PaaS/IaaS). - Develop and execute validation strategies aligned with 21 CFR Part 11, EU Annex 11, and GAMP 5. - Author and maintain validation lifecycle documentation (e.g., plans, URS, risk assessments, traceabi...