Csv Site Lead

cslbehring.cl

Base: $138,000 - $164,000; bonus/equity: incentive...
Csv strategy for ot platforms
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.
  • The CSV Site Lead provides governance, expertise, and oversight to the site automation teams and partners, ensuring robust digital and vendor QMS controls, inspection readiness, and sustainable CSV capability across the site.

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
  • Maintain validated state of OT systems
  • CSV framework, SOPs, templates
  • Vendor QMS governance
  • Regulatory, audit, data integrity support
  • Cross-functional collaboration

Nice-to-have

  • External partner model management
  • Continuous improvement in quality
  • Inspection readiness driving
  • Sustainable CSV capability building

Key Requirements

  • 7+ years experience with CSV methodologies
  • Knowledge of CSV regulations and SDLC guidelines
  • Experience with Lab, Automation and MES projects
  • Experience writing, reviewing, executing CSV documentation
  • Exposure to Execution Systems technologies
  • Knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP5
  • Experience defining and implementing CSV partner model

Work Rights

Not specified

Tailored Resume

Cover Letter