Qualification & Validation Coordinator – Life Sciences

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. 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 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 . 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