Csv Site Lead

CSL Behring

Base: $138,000 - $164,000; bonus/equity: incentive...
Computerized system validation (csv)
Operational technology (ot) platforms
Csv partner model governance
The CSV Site Lead is accountable for developing and governing the CSV strategy for site OT platforms supporting Manufacturing and QC Laboratories, ensuring alignment with global standards and regulatory expectations

Job Summary

  • The CSV Site Lead is accountable for developing and governing the CSV strategy for site OT platforms supporting Manufacturing and QC Laboratories, ensuring alignment with global standards and regulatory expectations.
  • This role provides governance, expertise, and oversight to site automation teams and external partners, maintaining validated states of OT systems and ensuring inspection readiness.
  • CSL Behring is a global biotherapeutics leader focused on innovative therapies and operates one of the world’s largest plasma collection networks, employing 32,000 people worldwide.

Matching Summary

The CSV Site Lead is accountable for developing and governing the CSV strategy for site OT platforms supporting Manufacturing and QC Laboratories, ensuring alignment with global standards and regulatory expectations.

Salary

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

Skills & Requirements

Must-have

  • Computerized System Validation (CSV)
  • Operational Technology (OT) platforms
  • CSV partner model governance
  • Regulatory compliance and audit readiness
  • Validation lifecycle management
  • Risk-based validation methodology
  • Vendor QMS governance

Nice-to-have

  • Cross-functional collaboration
  • Continuous improvement and innovation
  • Stakeholder engagement
  • Training and capability building
  • Strategic planning and leadership

Key Requirements

  • Bachelor of Science in Engineering, Automation, or Computer Science
  • 7+ years experience in CSV methodologies
  • Experience with pharma, biotechnology, chemistry, or food industries
  • Knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP5
  • Experience with IQ, OQ, PQ documentation and regulatory inspections
  • Experience defining and implementing CSV partner models

Work Rights

Not specified

Tailored Resume

Cover Letter