Summary:

The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational requirements throughout the system lifecycle. The role focuses on traditional Computer System Validation with application of risk-based Computer Software Assurance (CSA) principles where appropriate.

The individual will work closely with IT and Quality teams to validate and maintain GxP systems across their lifecycle. Strong experience validating relational databases, cloud infrastructure, and integrated applications in regulated biotech or pharmaceutical environments is required.

This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.

This is a hybrid role with minimum of 3 days a week onsite at San Carlos, CA location.

Essential Functions:

• 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.
• Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
• Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.

Requirements: 

• 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. Other combinations of education and/or experience may be considered.
• 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.

Other combinations of education and/or experience may be considered.

Preferred Qualifications:

• Hands-on experience validating cloud based GxP systems, specifically Azure.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
• Experience applying CSA principles to custom data applications in GxP cloud.
• Microsoft Azure or similar technical certifications.