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
$138,000 - $164,000 base salary
Skills & Requirements
Must-have
CSV strategy for OT platforms
external partner model
validated state maintenance
vendor QMS governance
regulatory inspection support
Nice-to-have
continuous improvement
stakeholder engagement
strategic planning
inclusion and belonging
Key Requirements
7+ years experience with CSV methodologies
Demonstrated knowledge of CSV regulations
Experience with Lab, Automation and MES projects
Experience writing, reviewing and executing CSV documentation
Bachelor of Science in Engineering, Automation, or Computer Science