Qualification & Validation Coordinator – Life Sciences

About the role

ALTEN, a global engineering and technology consulting group, is looking for a Qualification & Validation Coordinator in Brussels. You will support the projects of partners active in the production of medicines or health-related products, coordinating and running the validation cycle so that projects are completed on time.

Key responsibilities

• Represent the Validation department on various projects
• Design and implement the validation strategy
• Coordinate project planning with Production, QA and Maintenance
• Draft a Risk Assessment and contribute to Functional and Design Specifications
• Write protocols and run URS, FAT, SAT, IQ, OQ and PQ tests, then analyse results and write reports
• Develop training sessions and coach operators
• Manage validation deviations and implement the associated CAPAs

Required profile

• Degree in Engineering, a Master's in Bioengineering, Industrial Pharmacy or a related field
• Experience in qualification and validation within a GMP environment
• Knowledge of pharmaceutical production processes
• Ability to work in both English and French
• Curiosity about production equipment and manufacturing processes
• Meticulous in drafting GMP documentation and able to communicate across Production, QA and Maintenance