Qualification & Validation Coordinator – Life Sciences

ALTEN is a world leader in Engineering and Technology Consulting with almost 60 000 employees, 88% of whom are engineers.

Operating in more than 30 countries, the Group supports its customers' development strategy in the areas of engineering, innovation, R&D and technological information systems.

Why choose ALTEN?

• It is a great opportunity to take part in the greatest technological challenges
• Working in a collaborative work environment provides close support
• We are a real career booster in France and abroad

Job Description As a Qualification and Validation Consultant, your expertise will support the projects of our partners whose activities are established in the production of medicines or health-related products.

You will play a central role in coordinating and executing the validation cycle with the aim of successfully completing projects within the given timelines.

To do so, you will:

• Represent the Validation department on various projects;
• Design and implement the best Validation strategy;
• Coordinate project planning with all stakeholders (Production / QA / Maintenance);
• Participate in risk assessment through the drafting of a "Risk Assessment";
• Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
• Write protocols, coordinate, and ensure the proper execution of tests (URS / FAT / SAT / IQ / OQ / PQ);
• Analyze and interpret results in order to draft the corresponding reports;
• Develop training sessions and coach operators in the field; Manage deviations related to validation runs and implement the associated CAPAs.

Qualifications

• A degree in Engineering, a Master’s in Bioengineering, Industrial Pharmacy, or related fields;
• Experience in qualification and validation within a GMP environment;
• Knowledge of production processes in the pharmaceutical industry;
• The ability to work in English as well as French.
• Curious to learn more about production equipment and/or manufacturing processes;
• Organized and meticulous in drafting your GMP documentation;
• Communicative and enjoy interacting with various departments such as Production / Quality Assurance / Maintenance.

Additional Information Our approach to sustainable development and social responsibility is built on three fundamental pillars :

People We celebrate the rich diversity of our employees, who represent over 100 nationalities . We are committed to fostering an inclusive environment where everyone can thrive and make a meaningful contribution. We encourage skill development and actively support our talent in their personal and professional growth .

Environment Our mission is to minimize our environmental footprint while promoting sustainable growth . We are committed to achieving carbon neutrality by 2050 , a goal that guides our operations and shapes our strategic initiatives.

Sustainable Innovation At ALTEN, we see the challenges of sustainable development as opportunities to drive research and innovation . With 31% of our internal R&D dedicated to sustainable innovation , we are determined to turn these challenges into value-creating and progress-driven solutions .