Senior CSV Engineer: Cloud GxP Systems Validation

Regulatory Jobs; San Carlos (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Vaxcyte in San Carlos, CA seeks a Senior CSV Engineer to lead validation of cloud-based GxP systems across the lifecycle, ensuring regulatory compliance, quality, and data integrity.

You will collaborate with IT and Quality to author and execute validation protocols, perform risk assessments, and maintain traceability matrices. Regulated biotech experience with databases, cloud infra, and integrated apps is required. Hybrid role with 3 onsite days weekly.

Qualifications

• Experience validating cloud-based GxP systems.
• Familiarity with CSA principles for software assurance.
• Proven ability to author and review validation documentation.

Responsibilities

• Hands-on lead full lifecycle Computer System Validation for cloud-based GxP systems including databases and applications.
• Author, update, execute and maintain validation deliverables (Validation Plans, URS, FSS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ, Summary Reports).
• Perform risk assessments to define validation scope and testing strategy per CSA.
• Define and execute validation strategies for data platforms and components with data integrity in mind.
• Assess and validate end-to-end data flows between upstream and downstream systems for accuracy and traceability.
• Evaluate system changes for validation impact and maintain compliance through testing and documentation.

Skills

Cloud-based GxP validation

CSA principles

Validation deliverables

Risk assessment

Data integrity

Documentation

Tools

Relational databases

Cloud infrastructure

Integrated applications

Job description

Vaxcyte in San Carlos, CA seeks a Senior CSV Engineer to lead validation of cloud-based GxP systems across the lifecycle, ensuring regulatory compliance, quality, and data integrity.

You will collaborate with IT and Quality to author and execute validation protocols, perform risk assessments, and maintain traceability matrices. Regulated biotech experience with databases, cloud infra, and integrated apps is required. Hybrid role with 3 onsite days weekly.