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.

Responsibilities

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.

Requirements

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.