Senior Computer Systems Validation Engineer

Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases. The Senior Computer Systems Validation Engineer will lead validation activities for cloud-based GxP systems, ensuring compliance with regulatory and quality standards throughout the system lifecycle. Responsibilities: 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 Qualifications: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience; Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems; Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations; Experience working in modern system environments utilizing CI/CD pipelines or automated release processes; Strong hands-on experience validating GAMP 5 systems for biotech manufacturing; Deep understanding of 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; Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders Required Skills: Computer System Validation, GAMP 5, Cloud based GxP systems, Risk-based validation methodologies, Computer Software Assurance (CSA), FDA 21 CFR Part 11, FDA 21 CFR Part 210, FDA 21 CFR Part 211, Annex 11, Data integrity requirements, IT infrastructure, Software engineering, Programming, Databases, Data integrations, CI/CD pipelines, Automated release processes, Validation documentation, Microsoft Azure, Infrastructure as code, GitHub, Terraform