Csv Site Lead

CSL Behring

$138,000 - $164,000 py
Csv strategy for ot systems
Governance of csv planning
Maintenance of validated state
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.
  • 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 systems
  • governance of CSV planning
  • maintenance of validated state
  • CSV framework and SOPs
  • vendor QMS governance
  • regulatory and audit support

Nice-to-have

  • continuous improvement in quality
  • building sustainable capability
  • cross-functional collaboration
  • inclusion and belonging

Key Requirements

  • 7+ years experience with CSV methodologies
  • Demonstrated knowledge of CSV regulations
  • 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

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