Senior CSV Engineer, Cloud GxP Systems – Hybrid

Vaxcyte, Inc; San Carlos (CA); Hybrid; USD 164,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte, Inc in San Carlos, CA, is seeking a Senior Computer Systems Validation Engineer to lead validation activities for cloud-based GxP systems. The role requires extensive experience validating databases and applications within regulated biotech environments, focusing on compliance with FDA regulations.

This hybrid position mandates a minimum of 3 days onsite each week. Candidates should have a Bachelor's degree and at least 7 years of relevant validation experience. Comprehensive benefits and competitive salary between $164,000 and $190,000 are included.

Qualifications

• Minimum 7 years of experience in Computer System Validation within biotech.
• Deep understanding of FDA 21 CFR requirements.
• Strong hands-on experience validating GxP systems.

Responsibilities

• Lead lifecycle Computer System Validation activities for cloud-based GxP systems.
• Author, execute validation deliverables like Validation Plans and Risk Assessments.
• Participate in internal audits and regulatory inspections.

Skills

Technical knowledge of IT infrastructure

Software engineering

Strong technical writing skills

Communication skills

Experience with CI/CD pipelines

Education

Bachelor’s degree in Computer Science or related field

Tools

GAMP 5 systems

Azure

GitHub

Terraform

Job description

Vaxcyte, Inc in San Carlos, CA, is seeking a Senior Computer Systems Validation Engineer to lead validation activities for cloud-based GxP systems. The role requires extensive experience validating databases and applications within regulated biotech environments, focusing on compliance with FDA regulations.

This hybrid position mandates a minimum of 3 days onsite each week. Candidates should have a Bachelor's degree and at least 7 years of relevant validation experience. Comprehensive benefits and competitive salary between $164,000 and $190,000 are included.