Senior CQV CSV Engineer: Cloud & AI Validation

MindCapture; Belgique; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

MindCapture in Ghent is offering a senior consultant role focused on validating computer systems in regulated environments. You will lead validation and qualification activities across digital platforms, ensuring compliance with FDA/EU standards, data integrity and AI governance.

The role involves collaborating with quality, data, product and security teams on site with clients, enabling impactful, long-term improvements in patient care through rigorous validation practices.

Qualifications

• Significant experience as a validation consultant or quality manager for computer systems in regulated pharma/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.
• Experience qualifying infrastructure, data and cloud platforms.
• Hands-on with cloud data warehouses, data visualisation tools and data processing frameworks.
• Experience validating complex AI solutions and applying AI governance principles.

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 CAPAs.
• 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

Systems knowledge

Formation

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

Description du poste

MindCapture in Ghent is offering a senior consultant role focused on validating computer systems in regulated environments. You will lead validation and qualification activities across digital platforms, ensuring compliance with FDA/EU standards, data integrity and AI governance.

The role involves collaborating with quality, data, product and security teams on site with clients, enabling impactful, long-term improvements in patient care through rigorous validation practices.