Csv Site Lead

CSL Behring

$138,000 - $164,000; not specified; not specified ...
Operational technology (ot) systems
Computerized system validation (csv)
External partner model
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

  • Operational Technology (OT) systems
  • Computerized System Validation (CSV)
  • external partner model
  • validated state maintenance
  • regulatory expectations
  • vendor QMS governance

Nice-to-have

  • continuous improvement
  • stakeholder engagement
  • strategic innovation
  • inclusion and belonging

Key Requirements

  • 7+ years experience with CSV methodologies
  • Bachelor of Science in Engineering, Automation, Computer Science
  • Experience with Lab, Automation and MES projects
  • Experience writing, reviewing and executing CSV documentations
  • Knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP5

Work Rights

Not specified

Tailored Resume

Cover Letter