Sr. CSV Engineer

Roles & Responsibilities: Lead the validation and compliance of multiple systems, including Historian connections, SAP integrations, and Warehouse Execution Systems (AizoOn, Swisslog), ensuring readiness for serialization L3 and L4 processes Collaborate closely with client teams and internal stakeholders to define requirements, support workflows, and ensure smooth system implementation Execute infrastructure qualification (both virtual and physical) and support system commissioning while adhering to regulatory compliance standards Support SAP-connected processes such as purchase orders, inventory management, and integration with existing instances, coordinating with global teams as needed Interface with the global compliance and engineering teams to address gaps, provide guidance, and maintain alignment on system validation priorities Assist with smaller-scale system validation projects (e.g., Maximo) as required, providing technical expertise while ensuring compliance with applicable standards Education & Experience : Bachelor's degree in Engineering or a related life sciences/technical discipline 5+ years of experience in Computer System Validation (CSV) with multiple systems, including SAP, Warehouse Execution Systems (AizoOn, Swisslog), and Historian connections, preferably supporting L3/L4 serialization Strong ability to collaborate with client and global teams to define requirements, support workflows, and execute infrastructure qualification (virtual and physical) in compliance with regulatory standards Proven experience managing system integrations, purchase order/inventory processes, and smaller-scale validation projects (e.g., Maximo), ensuring adherence to compliance and validation best practices

Created: 2026-04-02