Csv Site Lead

CSL BEHRING

United States
Base: $138,000 - $164,000; bonus/equity: incentive...
Csv strategy for ot platforms
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

Base: $138,000 - $164,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • CSV strategy for OT platforms
  • external partner model
  • validated state maintenance
  • vendor QMS governance
  • regulatory inspection support
  • data integrity principles

Nice-to-have

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

Key Requirements

  • 7+ years experience with CSV methodologies
  • Bachelor of Science in Engineering, Automation, or Computer Science
  • Experience with Lab, Automation and MES projects
  • Experience in 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