$138,000 - $164,000; not specified; not specified ...
Csv strategy for ot systems
External partner model
Validated state maintenance
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.
Operating primarily through an external partner model, 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; Not specified; Not specified
Skills & Requirements
Must-have
CSV strategy for OT systems
external partner model
validated state maintenance
vendor QMS governance
regulatory inspection support
data integrity principles
Nice-to-have
continuous improvement
stakeholder engagement
strategic planning
capability building
Key Requirements
7+ years experience with CSV methodologies
CSV regulations and SDLC guidelines
Experience with Lab, Automation and MES projects
Writing, reviewing and executing CSV documentations
Experience defining and implementing a CSV partner model