CSV Engineer Infrastructure

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

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

In this role, you will support computer systems lifecycle management and IT quality processes within a regulated environment. You will lead validation and qualification activities, ensure compliance with global regulations and industry standards, manage quality events and provide expert guidance on data integrity, cloud technologies and artificial intelligence validation.

Key responsibilities

• Validation documentation: Write, review and approve validation and qualification deliverables
• Compliance oversight: Ensure alignment with regulatory requirements, internal procedures and industry standards
• Project support: Deliver complete and consistent validation activities within agreed timelines
• Issue management: Record and communicate project related issues to the appropriate stakeholders
• Documentation: Develop and review validation and qualification procedures and templates
• Quality events: Manage change controls, deviations and corrective and preventive actions
• Stakeholder collaboration: Communicate effectively with quality, data, product and security teams
• Validation expertise: Support computer system validation and qualification across digital technology platforms

Required competences & skills

• Validation experience: Significant experience as a validation consultant or quality manager for computer systems in regulated pharmaceutical or biotechnology environments
• Regulatory expertise: Strong knowledge of FDA 21 CFR Part 11, EU Annex 11 and relevant industry standards
• Data integrity: Expert knowledge of data integrity controls, risk assessments, GAMP 5 and Computer Software Assurance principles
• Cloud technologies: Significant experience qualifying infrastructure, data and cloud platforms
• Data platforms: Hands on experience with cloud data warehouses, data visualisation tools and data processing frameworks
• AI validation: Experience validating complex artificial intelligence solutions and applying AI governance frameworks
• Communication: Strong communication and stakeholder management skills across multidisciplinary teams
• Education: Bachelor’s or master’s degree in computer science, life sciences, engineering or a related discipline
• Systems knowledge: Experience with electronic quality management or IT service management systems is a plus

CQV Ghent Senior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.