Kodiak Sciences

Validation Engineer

Kodiak Sciences  •  Palo Alto, CA (Onsite)  •  16 days ago
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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, 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).
Kodiak Sciences

About Kodiak Sciences

Kodiak is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak's discovery engine. Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein for the treatment of retinal inflammatory diseases. We are advancing our platform technology to embed small molecules and other active pharmaceutical ingredients for multifactorial diseases.

WORKING AT KODIAK

We foster a culture of curiosity, creativity, compassion and courage. Our collective goal is to make a difference in the world. We do that as a team driven by the shared desire to tackle some of the world’s biggest challenges. If this sounds exciting, we want to hear from you!

Kodiak supports a vibrant and active lifestyle, striving to provide an optimal work-life balance. We are located in Palo Alto, in the heart of the world-class biotech hub of Silicon Valley, and within walking distance to California Avenue’s shops, restaurants and public transportation.

Industry
Biotech & Life Sciences
Company Size
51-200 employees
Headquarters
Palo Alto, California
Year Founded
2009
Website
kodiak.com
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