Computer System Validation Engineer

at  Sopra Steria

Sopra Steria Group, a major player in consulting, technology services and software publishing in Europe, assists its clients in the successful transformation of their business and information systems. By combining value and innovation in the solutions proposed, and delivering utmost quality and performance in the services provided, Sopra Steria Group positioned itself as a preferred partner for major companies and organizations; especially those looking for the best use of digital technology for their development and competitiveness.

YOUR KNOWLEDGE AND EXPERIENCE:

• Graduate with a Master’s degree in a scientific direction (Industrial Engineer, Bio Engineer, Chemistry, Biotechnology, Pharmacy,…) or equivalent by experience.
• Familiar with regulatory standards and guidelines (GAMP5, EU Annex 11, 21CFR Part 11, ISO9001…) and concepts such as QMS, Da-ta Integrity, CAPAs, GDPR,… .
• Knowledge of validation methodologies (Waterfall, Agile) within a GxP environment.
• Affinity with IT and basic knowledge of IT infrastructure qualification.
• Analytical and pragmatic thinking.
• Strong prioritization and planning skills.
• Strong sense of responsibility and accountability.
• Excellent communication skills in Dutch and English.

• You advise the customer regarding the applicable regulations for your project/system.
• You are responsible for defining and documenting a risk-based validation approach for your project/system.
• You plan and manage all validation activities required for your project/system.
• You (co-)write validation documentation (e.g. Validation Plan/Report, System Criticality Assessment, User Requirements, …) and testing documentation (Test Plan/Report, Test Scripts, …).
• You are in close contact with various system/project stakeholders and understand the interests and needs of business, IT and Quality Assurance.
• You (co-)write procedures (SOPs, Work Instructions) related to the use of your system.
• You are responsible for keeping your system in a validated state.
• You are able to provide system-specific validation support during audits and inspections.