Csv Site Lead

cslbehring.de

Base: $138,000 - $164,000; bonus/equity: incentive...
Csv strategy for ot platforms
External partner model
Validated state of ot systems
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.
  • The expected base salary range for this position at hiring is $138,000 - $164,000.

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 of OT systems
  • digital and vendor QMS controls
  • CSV procedures, work instructions, templates
  • vendor QMS integration governance

Nice-to-have

  • continuous improvement in quality
  • inspection readiness
  • sustainable CSV capability
  • stakeholder engagement
  • strategic innovation

Key Requirements

  • 7+ years experience with CSV methodologies
  • Experience with 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, Computer Science

Work Rights

Not specified

Tailored Resume

Cover Letter