Learn from our expert: an interview with Amelie, Consulting Qualification Validation Leader

Who am I? What are my roles?

Hello, my name is Amélie, I’m 29 years old and I’m an engineer graduated from the Ecole de Biologie Industrielle. I have been working for 3 years within ProductLife Group as a qualification manager in the pharmaceutical industry. Today I have a dual mission within PLG; I am both a consultant deployed on various projects, and I am also Team leader of the CQV team within ProductLife Group.

What do I like about these missions?

Regarding the qualification activity, what I like is going on the field, constantly working with completely different people and departments, whether it’s a project manager, production operators, maintenance technicians, or managers of the different services. I also have the opportunity to work on completely different projects, and the most satisfying thing is to see a project succeed after several months of work.

Concerning the Team leader activity, it is above all the human contact that we have with our teams which is very stimulating. As a consultant, this is a contact that can be a little lacking when you are deployed independently to a client’s factory.

What does the job of qualification engineer consist of?

In a few words, the qualification engineer is responsible for verifying the conformity of production equipment and premises with the specifications and current regulatory requirements.

What do you think are the main qualities required for this position?

I think it is essential to have good interpersonal skills, because, as I said a little before, we have to be in contact with a lot of very varied actors. Having good organizational skills is also important for this type of position. I have many times had to work on several projects at once, so you have to know how to keep a cool head and prioritize tasks.

What does the job of validation qualification engineer consist of?

The role of a validation qualification engineer is to ensure, during the implementation of a project, the safety and quality of the system (system, software, equipment, premises and utilities) installed or modified. We intervene at each stage of the project to ensure that the proposed solution is in accordance with the specifications (URS), but above all with the standards and current regulations.

What challenges for tomorrow’s industry?

If in recent decades, the industry has focused on environmental themes, I think that the major challenge in the years to come will concern the appearance of AI, particularly in the health industries. This development will undoubtedly make it possible to optimize the time spent on tasks with lower added value but will necessarily require the appearance or modification of standards dedicated to the regulation of this use and security (e.g. ISO 42001 standard).

What advice for future engineers?

I think the most important thing to keep in mind, whether during studies or when looking for a job, is to have confidence in your qualities. Once we have confidence in ourselves and our qualities, it is easier to be open-minded, and above all proactive. I think these are qualities that all engineers have in common, and which allow us to evolve both professionally and personally.