Qualification & Validation Engineer

Responsibilities

• Represent the Validation department on various projects
• Design and implement validation strategies
• Coordinate project planning with Production, QA, and Maintenance stakeholders
• Participate in risk assessments and draft documentation
• Contribute to the definition of Functional and Design Specifications
• Write protocols and coordinate the execution of tests (URS, FAT, SAT, IQ, OQ, PQ)
• Analyze and interpret results to draft corresponding reports
• Develop training sessions and coach field operators
• Manage deviations and implement associated CAPAs

Requirements

• Degree in Engineering, Master’s in Bioengineering, Industrial Pharmacy, or related fields
• Experience in qualification and validation within a GMP environment
• Knowledge of pharmaceutical production processes
• Fluency in English and French
• Strong organizational and meticulous drafting skills
• Excellent communication skills for cross-departmental interaction

About the Company

ALTEN is a world leader in Engineering and Technology Consulting with almost 60,000 employees. The Group supports customers' development strategies in engineering, innovation, R&D, and technological information systems across more than 30 countries.