Equipment Qualification QCS Senior Engineer

Prothya Biosolutions; Brussel; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Prothya Biosolutions in Belgium seeks a Senior Engineer Equipment Qualification QCS to join our Global Quality Control Support team. You will drive qualification, validation, maintenance and lifecycle management of analytical equipment and computerized systems used in Quality Control and Production.

You will lead qualification and validation projects, define URS and manage IQ/OQ/PQ activities while ensuring Data Integrity and compliance with GMP, FDA, EMA guidelines.

Qualifications

• Strong experience in equipment qualification and computerized system validation within a GMP-regulated environment.
• Solid knowledge of Data Integrity principles, GMP, GDP, FDA, EMA, and ICH guidelines.
• Proven project management and stakeholder management skills.
• Experience with analytical laboratory instruments and quality systems.
• Proactive mindset with a passion for continuous improvement and compliance excellence.

Responsabilités

• Lead qualification and validation projects for new analytical instruments and computerized systems
• Define User Requirement Specifications (URS) and manage IQ/OQ/PQ activities
• Ensure Data Integrity and regulatory compliance (Annex 11, 21 CFR Part 11)
• Manage calibration, re-qualification, preventive maintenance, and supplier contracts
• Support audits and inspections as SME
• Drive Data Integrity improvement and remediation projects
• Investigate QC alarms and implement CAPAs
• Lead continuous improvement, digitalization, and automation initiatives
• Collaborate with QC, Production, QA, IT and external partners

Connaissances

Equipment qualification

Computerized validation

Data Integrity

GMP guidelines

Project management

Stakeholder management

Continuous improvement

Description du poste

At Prothya Biosolutions, we develop life‑saving plasma‑derived medicines that improve the lives of millions of patients worldwide. To support our continued growth, we are looking for a Senior Engineer Equipment Qualification QCS to join our Global Quality Control Support team.

Your Impact

As a Senior Engineer Equipment Qualification QCS, you will be the driving force behind the qualification, validation, maintenance, and lifecycle management of analytical equipment and computerized systems used in Quality Control and Production environments.

What You’ll Do

• Lead qualification and validation projects for new analytical instruments and computerized systems
• Define User Requirement Specifications (URS) and manage IQ/OQ/PQ activities
• Ensure compliance with Data Integrity, Annex 11, and 21 CFR Part 11 regulations
• Manage calibration, re‑qualification, preventive maintenance, and supplier contracts
• Support audits and inspections as Subject Matter Expert (SME)
• Drive Data Integrity improvement and remediation projects
• Investigate QC alarms and implement CAPAs
• Lead continuous improvement, digitalization, and automation initiatives
• Collaborate closely with QC, Production, QA, IT teams, and external partners

What We’re Looking For

• Strong experience in equipment qualification and computerized system validation within a GMP‑regulated environment
• Solid knowledge of Data Integrity principles, GMP, GDP, FDA, EMA, and ICH guidelines
• Proven project management and stakeholder management skills
• Experience with analytical laboratory instruments and quality systems
• Proactive mindset with a passion for continuous improvement and compliance excellence

Why Join Prothya?

At Prothya, every colleague contributes to improving patients’ lives.

We offer:

• Extensive training and development opportunities
• International career opportunities within a growing biopharmaceutical organization
• Most importantly, you’ll join a company where innovation, collaboration, diversity, and respect are at the heart of everything we do.

Ready to make a difference?

Apply now and become part of a team dedicated to delivering life‑saving therapies to patients around the world.