Life Sciences Computer System Validation Engineer

Sopra Steria provides tailored, end-to-end enterprise technology and software solutions to help customers make bold choices and achieve results. As a Computerized System Validation (CSV) Engineer, you play a key role in the validation process of automated systems used by customers in the Life Sciences sector.

Requirements

• Proven CSV experience in multiple projects or strong interest in CSV
• Strong affinity with IT
• Analytical and pragmatic thinking
• Strong prioritization and planning skills
• Strong sense of responsibility and accountability
• Positive, solution-oriented mindset
• Excellent written and verbal communication skills in Dutch and English
• Basic knowledge of IT infrastructure qualifications
• A team player, but also able to work independently
• Familiar with applicable legal standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,....
• Knowledge of the application of validation methodologies (Waterfall, Agile) within a GxP environment

Benefits

• Extensive secondary employment conditions
• Continued learning opportunities through the Sopra Steria Academy
• The opportunity to connect with other Sopra Steria colleagues during various team events