Cardinal Health Computer System Validation Engineer (Remote) in United States
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.
This role will be responsible for:
- 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)
The individual should demonstrate:
- 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:
- A Bachelor’s degree in a technical/engineering discipline or equivalent experience
- 5-10 years of experience with FDA or EMEA standards and regulations in a process model for software development and computer system validation.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.