Senior Computer Systems Validation Engineer

Vaxcyte Inc

San Carlos, CA, United States
$164,000 - $190,000; not specified; comprehensive ...
On-site
Cloud gxp systems validation
Risk-based csa principles
Validate relational databases
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

Job 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.
  • This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.
  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

Matching 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.

Salary

$164,000 - $190,000; Not specified; comprehensive benefits

Skills & Requirements

Must-have

  • Cloud GxP systems validation
  • Risk-based CSA principles
  • Validate relational databases
  • Validate integrated applications
  • GAMP 5 systems validation
  • Data integrity requirements

Nice-to-have

  • Continuous improvement of validation
  • Kindness-first, inclusive approach
  • Creative and intellectual diversity

Key Requirements

  • Bachelor’s degree or equivalent experience
  • Minimum 7 years experience
  • Technical knowledge of IT infrastructure
  • Experience with CI/CD pipelines
  • Strong technical writing skills
  • FDA 21 CFR Part 11, Part 210, Part 211, Annex 11 knowledge

Work Rights

Not specified

Tailored Resume

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