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, traceability, IQ/OQ/PQ, reports).
• Validate system security, access controls, audit trails, data integrity, and backup/recovery processes.
• Collaborate cross-functionally (IT, QA, Clinical, Regulatory) and provide risk assessments for system changes.
• Present validation status, risks, and recommendations to leadership.
• Support audits/inspections as SME; defend validation approach and provide evidence.
• Drive continuous improvement of validation processes, templates, and scalable risk-based approaches.

Experience / Education

• 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).
• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• Ability to work onsite in Palo Alto (5 days a week).