Sr. CSV Engineer

Blue Ash, OH, US • Posted 1 day ago • Updated 14 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

System Implementation
Inventory Management
Life Sciences
Computerized System Validation
SAP
Warehouse
Network Layer
Collaboration
Workflow
Management
Purchase Orders
Inventory
Maximo
Regulatory Compliance

Summary

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
ssist 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 25ebe7c2972c0bf49b99239174425498
Posted 1 day ago

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Sr. CSV Engineer

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Job Details

Skills

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