Senior Computer Systems Validation Engineer

Role: Senior Computer Systems Validation Engineer leading validation activities for cloud-based GxP systems in a biotech environment, ensuring regulatory, quality, and operational compliance throughout system lifecycle. Responsibilities: authoring and executing validation plans, protocols, risk assessments, and validation reports; validating relational databases, cloud infrastructure (notably Azure), and integrated applications; assessing system changes and data flow integrity; supporting change control, audits, and continuous process improvements. Requirements: Bachelor's in Computer Science, Engineering, or Life Sciences; 7+ years in validation within biotech or pharmaceutical settings; strong expertise in GAMP 5, FDA 21 CFR Part 11, data integrity, and validation methodologies; hands-on experience with cloud platforms, CI/CD pipelines, and automated release processes; technical proficiency in databases, IT infrastructure, and software engineering. Preferred: Azure-specific validation experience, infrastructure as code (e.g., GitHub, Terraform), relevant certifications. Collaboration: reports to Senior Manager, Data Systems; works hybrid from San Carlos, CA, with a minimum of 3 days onsite.