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

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.

• 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.

Our approach tosustainable development and social responsibility is built onthree fundamental pillars:

People
We celebrate therich diversity of our employees, who represent over100 nationalities. We are committed to fostering aninclusive environment where everyone can thrive and make a meaningful contribution. We encourageskill development and actively support our talent in theirpersonal and professional growth.

Environment
Our mission is tominimize our environmental footprint while promotingsustainable growth. We are committed to achievingcarbon 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 asopportunities to drive research and innovation. With31% of our internal R&D dedicated to sustainable innovation, we are determined to turn these challenges intovalue-creating and progress-driven solutions.