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.
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
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 .