Sr. Computer Systems Validation Engineer

CooperCompaniesUnited States,

About The Position

The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.

Requirements

  • Strategic leadership
  • Technical expertise for validation, maintenance, and continuous improvement of computerized systems in regulated environments
  • Experience establishing and maintaining a corporate CSV framework
  • Experience overseeing critical programs and complex enterprise systems
  • Experience ensuring regulatory inspection readiness
  • Experience driving a risk-based, inspection-ready validation culture

Responsibilities

  • Validation of global computer systems
  • Monitoring changes with regulations
  • Assisting team members for CSI’s corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations
  • Establishing and maintaining the corporate CSV framework
  • Overseeing critical programs and complex enterprise systems
  • Ensuring regulatory inspection readiness
  • Driving a risk‑based, inspection‑ready validation culture across the organization
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