Life Sciences Computer system validation engineer

As an expert in quality and compliance, you will be responsible for ensuring that systems and processes GxP meet applicable regulatory requirements throughout their lifecycle. You will also be responsible for validating computer systems used by our clients in the life sciences sector.

Requirements

• Confirmed experience in CSV in several projects or strong interest in computer system validation
• Strong affinity with computing
• Analytical and pragmatic mindset
• Strong planning and prioritization skills
• Strong sense of responsibility and commitment
• Positive attitude, solution-oriented
• Excellent written and oral communication skills in Dutch and English
• Basic knowledge of computer infrastructure qualification
• Spirit of teamwork, while being able to work independently
• Knowledge of applicable regulatory standards and guidelines (21 CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) as well as concepts such as QMS, CAPA, data integrity,...
• Familiarity with the application of validation methodologies (Waterfall, Agile) in a GxP environment

Benefits

• A variety of benefits, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-checks, and more
• Opportunities for continuous learning via the Sopra Steria Academy to support your professional development
• The opportunity to connect with your Sopra Steria colleagues at various team events