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 systems
Governing CSV planning and delivery
Maintaining validated state of OT systems
CSV framework, SOPs, templates
Vendor QMS governance for CSV
Regulatory, audit, and data integrity support
Nice-to-have
Building sustainable CSV capability
Cross-functional collaboration
Driving continuous improvement
Inspection readiness
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
Exposure to Execution Systems technologies
Knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP5
Demonstrated experience defining and implementing a CSV partner model