Computerized Systems Validation (CSV) Engineer
Our client is a medical devices organization focused on the research and development, production and commercialization of eye care products.
As a CSV Engineer within the Quality Department, your main role is to provide technical expertise and guidance with regards to computerized software validation.
- Provide technical expertise and guidance with regards to the computerized system lifecycle and perform activities as needed.
- Provide independent Quality review and approval of CSV deliverables and ongoing GxP related change controls.
- Provide Quality and CSV oversight to ensure compliance with applicable regulatory requirements and Johnson & Johnson policies and procedures throughout the system life cycle.
- Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle.
- Manage and execute Periodic Reviews per schedules.
- Implement controls to ensure data integrity and traceability of Quality records.
- Support process validations (IQ/OQ/PQ) and test method validation, where needed.
- Identify critical areas for improvement and prioritize and execute the initiatives resulting from this. As needed, perform or support nonconformance / CAPA root cause investigations, defining action plans and driving these to completion.
- Responsible for inspection readiness of the projects in scope of your work, and act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA)
- Bachelor's degree in relevant area
- Minimum 5 years of relevant work experience, preferably in automated processes within the pharmaceutical or medical device industry.
- Experience in Software Development Life Cycle processes
- Knowledge of computerized systems validation, validation of products/equipment/processes, statistics, risk management, change control, and data integrity.
- Working knowledge of relevant Medical Device regulations.
For more information please contact Ece Karakurt at email@example.com or +31 (0) 20 658 98 01.