CSV Engineer R&D — Quality & Validation

MindCapture; Belgique; À distance; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture Ghent is seeking a Senior consultant to manage validation and quality processes for regulated computer systems in healthcare R&D. The role focuses on compliance and documentation within GLP/GCP environments and requires experience with FDA/EU regulations and data integrity.

The successful candidate will work on cloud-based platforms, collaborate with cross-functional teams, and contribute to patient care through validated IT systems. On-site with our client in Ghent, Belgium.

Qualifications

• Significant experience as a validation consultant or quality manager for computer systems in regulated pharma/biotech environments
• Deep familiarity with FDA 21 CFR Part 11, EU Annex 11 and ICH guidance for data management
• Strong experience supporting computer systems within GLP and GCP environments
• Hands-on experience with cloud-based software platforms for biotech and life sciences research
• Experience managing early drug discovery, clinical, preclinical, biomarker and omics data
• Expert knowledge of data integrity controls, risk assessments, GAMP 5 and Computer Software Assurance
• Familiarity with governance frameworks for generative AI and LLMs
• Strong communication across scientific, quality, data, product and security stakeholders
• Bachelor’s or master’s degree in related fields
• Experience with electronic quality management or IT service management systems is a plus

Responsabilités

• Establish quality frameworks that keep computer systems secure and compliant
• Ensure project deliverables are complete and on schedule
• Record and communicate project-related issues to stakeholders
• Write and review validation and qualification procedures and templates
• Resolve computer system validation and qualification compliance issues
• Create and manage change controls, deviations and CAPAs
• Maintain open communication with multidisciplinary stakeholders
• Apply data integrity controls and risk-based validation levels

Connaissances

Validation expertise

Regulatory knowledge

Regulated environments

Digital platforms

Research data

Data integrity

AI governance

Collaboration

Education

Formation

Bachelor’s or Master’s degree in computer science or life sciences

Outils

eQMS/ITSM systems

Description du poste

MindCapture Ghent is seeking a Senior consultant to manage validation and quality processes for regulated computer systems in healthcare R&D. The role focuses on compliance and documentation within GLP/GCP environments and requires experience with FDA/EU regulations and data integrity.

The successful candidate will work on cloud-based platforms, collaborate with cross-functional teams, and contribute to patient care through validated IT systems. On-site with our client in Ghent, Belgium.