Csv Site Lead

CSL SEQIRUS

IL, United States
$138,000 - $164,000; not specified; not specified ...
Csv strategy for ot systems
External partner model
Validated state maintenance
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; Not specified; Not specified

Skills & Requirements

Must-have

  • CSV strategy for OT systems
  • external partner model
  • validated state maintenance
  • CSV framework and SOPs
  • vendor QMS governance
  • regulatory inspection support

Nice-to-have

  • continuous improvement
  • stakeholder engagement
  • strategic planning
  • innovation and value orientation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter