$138,000 - $164,000; not specified; not specified ...
Csv strategy for ot systems
Maintain validated state for ot platforms
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.
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
Maintain validated state for OT platforms
CSV framework, SOPs, templates
Vendor QMS governance
Regulatory, audit, and data integrity support
Cross-functional collaboration
Nice-to-have
Continuous improvement and innovation
Strategic planning
Stakeholder engagement
Delivering enterprise results
Key Requirements
7+ years experience with CSV methodologies
Experience with Lab, Automation and MES projects
Experience writing, reviewing and executing CSV documentations
Knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP5
Bachelor of Science in Engineering, Automation, Computer Science