Global Lead IT Computer System Validation (CSV) | Br...

🌍 Global Lead – IT Computer System Validation (CSV)

Location: Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam)

Department: IT

Reports to: Enterprise IT Architect.

Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At Prothya Biosolutions, we’re looking for a Global Lead IT CSV to drive validation excellence across our computerized systems and ensure they meet the highest regulatory standards.

🎯 Your Mission

As our Global Lead for IT CSV, you’ll lead validation efforts across the organization, ensuring systems are fit for purpose, compliant, and aligned with GxP requirements. You’ll collaborate with cross-functional teams, mentor IT professionals, and shape validation strategies that support operational efficiency and regulatory compliance.

🛠️ Key Responsibilities

• Develop Validation Strategies
• Design tailored validation approaches aligned with user needs, system requirements, and global regulations (GAMP, EU Annex 11, FDA 21 CFR Part 11).
• Execute Validation Protocols
• Lead IQ/OQ/PQ activities, coordinate testing, document results, and manage deviations in line with internal CSV procedures.
• Conduct Risk Assessments
• Evaluate GMP-criticality of systems and changes, identify compliance gaps, and implement mitigation strategies.
• Train & Mentor
• Educate IT teams on CSV processes and regulatory expectations. Act as the go-to expert for system qualification and validation.
• Drive Continuous Improvement
• Review and enhance validation processes based on industry trends and regulatory updates to boost efficiency and compliance.
• Manage Documentation
• Oversee creation and storage of validation documentation, ensuring audit-readiness and proper archiving.
• Collaborate Across Functions
• Work closely with IT, Automation, Production, QA, QC, Medical Affairs, and Supply Chain to align validation strategies and decisions.

👤 Your Profile

• Minimum 5 years of experience in CSV, ideally within the pharmaceutical sector.
• Proven track record in validation strategy development, risk assessments, and execution of validation protocols.
• Strong knowledge of GAMP5, 21 CFR Part 11, EU Annex 11, and pharmaceutical quality systems.
• Conceptual understanding of IT and IT-OT architecture, including networks, applications, and automation systems.
• Experience with Document Management Systems and Quality Management Systems.
• Fluent in English; Dutch is a plus.
• Analytical, pragmatic, and collaborative mindset.
• Able to handle time pressure and influence quality outcomes across systems.

Our Company

Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

We offer

Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.

We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).

Furthermore, we value mutual respect and diversity is our strength.

At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

Are you moving along? Then apply now!