Website Cardinal Health
The IT Risk & Compliance Management Computer System Validation Engineer is responsible to ensure the technology solutions for non-product software provided by Cardinal Health are compliant to the expectations set forth in government regulations in the countries in which Cardinal Health markets, sells, and distributes regulated products. This must be done in accordance with the good practice requirements for the manufacture and distribution of medical and pharmaceutical products.
- Strategizing, planning and detailing Computer System Validation (Change) Plans to ensure technical solutions and changes meet all applicable regulations and conform to the Cardinal Health Software Quality Assurance (SQA) Computer System Validation (CSV) Methodology.
- Demonstrates knowledge of impacted regulatory requirements and applies a risk-based approach to interpret and comply to these requirements.
- Coordinating with the Information Technology (IT) Solution Owner and the Business System (Process) Owner to establish the software validation approach as it relates to all aspects of the SDLC (Software Development Life Cycle) using industry standard methods (V-Model, Iterative, Waterfall, etc.).
- Bachelor’s degree in related field or equivalent work experience
- 4+ years experience in related field preferred
Company: Cardinal Health
Vacancy Type: Full Time
Job Location: Cleveland, OH, US
Application Deadline: N/A