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  • Location

    Groningen

  • Job title:

    CSV Engineer

  • Sector:

  • Job ref:

    46821

  • Start Date:

    2021-09-30

The Company 
Our client is a medical devices organization focused on the research and development, production and commercialization of eye care products.

Role Description 
As a CSV Engineer you will provide technical expertise and perform computerized systems validation activities. 

Responsibilities 
- 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)


Requirements
- 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)


Other Information
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01.

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804