Our client is a medical devices organization focused on the research and development, production and commercialization of eye care products.
As a CSV Engineer you will provide technical expertise and perform computerized systems validation activities.
- Provide technical expertise regards computerized system lifecycle and perform subsequent activities
- Quality and approval of CSV deliverables and ongoing GxP related change controls
- Provide Quality and CSV oversight to ensure compliance with internal requirements throughout systems lifecycle
- Ensure change control procedures are followed to maintain the system in a validated state throughout the life cycle
- Manage and execute Periodic Reviews
- Implement controls to ensure data integrity and traceability of Quality records
- Support process validations (IQ/OQ/PQ) and test method validation
- Perform or support non conformance / CAPA root cause investigations
- Inspection readiness of the projects 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 (ex. 21 CFR Part 820, 21 CFR Part 11)
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.