Csv Site Lead

cslbehring.ch

Base: $138,000 - $164,000; bonus/equity: incentive...
Csv strategy for ot systems
Maintain validated state of ot systems
Csv framework, sops, templates
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 systems
  • Maintain validated state of OT systems
  • CSV framework, SOPs, templates
  • Vendor QMS governance
  • Regulatory, audit, and data integrity support
  • Cross-functional collaboration

Nice-to-have

  • Continuous improvement and innovation
  • Strategic planning
  • Stakeholder engagement
  • Delivering enterprise results

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter