Cardinal Health Computer System Validation Engineer (Remote) in Dublin, Ohio
Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 25 on the Fortune 500.
We currently have a career opening for a Computer System Validation Engineer. This role is open to US based remote workers while serving as a full-time employee of Cardinal Health.
The Computer System Validation team is responsible to ensure the technology solutions for non-product software provided by Cardinal Health are compliant to the expectations set forth in the regulations and in accordance with the practice requirements for the manufacture and distribution of medical and pharmaceutical products.
- Determining the validation approach and managing all aspects of the SDLC approach for Computer System Validation projects (using V-Model, Iterative, Waterfall, etc.).
- Creation, maintenance and management of procedure or instruction development, document management concepts/processes and training delivery.
- Facilitating and documenting risk assessments to system requirements (e.g. intended use, functional risk).
- Applying quality methods in support of validation activities (e.g. good documentation practice, review or inspection, testing and test management, statistical sampling, internal/external audit management, troubleshooting, investigation or analysis tools/techniques)
- Knowledge in the US Code of Federal Regulation (CFR) and/or European Union (EMEA) regulations in medical device or pharmaceutical manufacturing, clinical or laboratory processes as they relate to Computer System Validation (e.g. 21 CFR Parts 11, 211, 212, 820, Medical Device Directive, ISO 13485, Annex 11).
- Knowledge of requirements engineering, test environments and protocols, functional risk assessment, Installation/Operational Qualification and Performance Qualification, defect and deviation management
- Knowledge of Project Management processes, Work Breakdown Structures and project estimation.
- Familiarity with Architecture Standards and concepts, configuration diagrams, infrastructure topology and schematics.
Education and experience should include:
- Proven industry experience with FDA or EMEA standards and regulations in a process model for software development and computer system validation.
- A Bachelor’s degree in a technical/engineering discipline or equivalent experience