Ingénieur Qualification & Validation

Description de l'offre

Mission: You will conduct commissioning, qualification & validation studies for manufacturing processes, equipment, utilities & cleaning validation.

As CQ&V expert, your role will support any operations that may affect the quality of the product:

You will have a key role in the definition of CQ&V strategies. Following the Validation strategy plan, you will help to define the global philosophy, the approaches to use & the planning to ensure the project’s completion.
You will ensure that all critical aspects & key elements of work are well defined & documented according to cGMP & FDA.
You will decide & prove whether utilities, premises & equipment are designed in accordance with cGMP & FDA
You will also ensure they have been built, installed & that they operate following their specifications.
You will actively participate on test coordination (FAT/SAT for example).
You will write & review CQ&V documentation such as Validation protocols, test sheets, validation reports according to SOP’s (standard operating procedures)
You will record & store your conclusions and will be responsible for all documents approvals.
Procedures, protocols & reports will be established based on your analysis & conclusions.
You may be involved in staff trainings.

Profil recherché

You hold a Master in Pharmaceutical or related studies
You have a first proven experience in process, validation, commissioning or qualification
You are fluent in English and/or French and/or Dutch
Corporate values mean a lot for us. We expect them to mean something for you

À propos de Nalys

Nalys is a consulting group dedicated to high technology projects.
Thanks to our strong corporate values and adhocracy management, we are one of the fastest growing actors in engineering consultancy.
We gather great minds & challenge boundaries to help our customers developing stunning products. And we love doing it.

Nalys is a people company. We will give you the opportunity to challenge yourself while doing something you love.
So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation,
develop your expertise, train your brains and give you time & tools to think big. 

Discover how we can give a sense to your passion on www.nalys-group.com