Hiring: Senior Computer Systems Validation Engineer Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-16 14:33:51 Employment Type: Hybrid Target Skills & Keywords : Azure, CI/CD, GitHub, Infrastructure as Code, Terraform About the job Experience: •7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered. •Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered. Required Skills: •Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications. •Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports. •Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles. •Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements •Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability. •Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation. •Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated. •Support change control, deviation management, periodic review, and lifecycle management of validated systems. Qualifications: •Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience. •Strong hands-on experience validating GAMP 5 systems for biotech manufacturing. •Comprehensive expertise in FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies. •Strong technical writing skills and ability to create comprehensive validation documentation. •Demonstrated capacity to communicate validation risks and requirements clearly to IT and Quality stakeholders. •Other combinations of education and/or experience may be considered. •Hands-on experience validating cloud based GxP systems, specifically Azure. •Operational familiarity with infrastructure as code frameworks like GitHub, Terraform etc. •Microsoft Azure or similar technical certifications. •Senior Manager, Data Systems Compensation: •$164,000 - $190,000 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!