Senior Computer Systems Validation Engineer

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

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHATwe do is every bit as important asHOWwe do it!Our work together is guided by four enduring core values:

• *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

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.