Csv Site Lead

CSL BEHRING

$138,000 - $164,000 py
Csv strategy for ot platforms
External partner model governance
Maintain validated state for ot
The CSV Site Lead is accountable for developing and governing the Computerized System Validation (CSV) strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories

Job Summary

  • The CSV Site Lead is accountable for developing and governing the Computerized System Validation (CSV) strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories.
  • Operating primarily through an external partner model, this role ensures that operational and Tier 2/3 CSV planning, resourcing and delivery are effectively executed, the validated state of OT systems is maintained across their lifecycle, and site practices align with quality, data integrity, and regulatory expectations.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

The CSV Site Lead is accountable for developing and governing the Computerized System Validation (CSV) strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories.

Salary

$138,000 - $164,000

Skills & Requirements

Must-have

  • CSV strategy for OT platforms
  • External partner model governance
  • Maintain validated state for OT
  • CSV framework, SOPs, templates
  • Vendor QMS governance
  • Regulatory, audit, data integrity support

Nice-to-have

  • Cross-functional collaboration
  • Capability building
  • Inclusion and Belonging
  • Continuous improvement and innovation

Key Requirements

  • 7+ years experience with CSV methodologies
  • Experience with CSV regulations and SDLC guidelines
  • Experience with Lab, Automation and MES projects
  • Experience writing, reviewing and executing CSV documentation
  • Bachelor of Science in Engineering, Automation, or Computer Science

Work Rights

Not specified

Tailored Resume

Cover Letter