Senior CSV Engineer – Cloud & AI Data Integrity

MindCapture; Belgique; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Meal vouchers and eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Professional training and development

On-site consultancy

Collaborative culture

Résumé du poste

MindCapture is seeking a Senior Validation Consultant to support computer systems lifecycle management and IT quality processes within a regulated environment in Belgium. You will lead validation activities, ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and apply data integrity and AI validation principles in collaboration with quality, data, product and security teams.

On-site engagement with top-tier healthcare institutions, with clear onboarding and ongoing professional development.

Qualifications

• Significant validation consultant or quality manager experience in regulated pharmaceutical/biotech environments.
• Strong knowledge of FDA 21 CFR Part 11, EU Annex 11 and relevant industry standards.
• Expert knowledge of data integrity controls, risk assessments, GAMP 5 and Computer Software Assurance principles.
• Significant experience qualifying infrastructure, data and cloud platforms.
• Hands-on experience with cloud data warehouses, data visualisation tools and data processing frameworks.
• Experience validating complex AI solutions and applying AI governance frameworks.
• Strong communication and stakeholder management across multidisciplinary teams.
• Bachelor’s or master’s degree in computer science, life sciences, engineering or related discipline

Responsabilités

• Write, review and approve validation and qualification deliverables
• Ensure alignment with regulatory requirements, internal procedures and industry standards
• Deliver complete and consistent validation activities within agreed timelines
• Record and communicate project related issues to stakeholders
• Develop and review validation and qualification procedures and templates
• Manage change controls, deviations and corrective and preventive actions
• Communicate effectively with quality, data, product and security teams
• Support computer system validation and qualification across digital technology platforms

Connaissances

Validation experience

Regulatory expertise

Data integrity

Cloud technologies

Data platforms

AI validation

Communication

Cross-disciplinary collaboration

Formation

Bachelor’s or master’s degree in computer science, life sciences, engineering or related

Description du poste

MindCapture is seeking a Senior Validation Consultant to support computer systems lifecycle management and IT quality processes within a regulated environment in Belgium. You will lead validation activities, ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and apply data integrity and AI validation principles in collaboration with quality, data, product and security teams.

On-site engagement with top-tier healthcare institutions, with clear onboarding and ongoing professional development.