A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: An exciting new opportunity has arisen to join us as Quality Assurance Engineer for our Biotech drug products plant in Aubonne.
As an integral member of the Quality Unit, you provide QA expertise for a new Aseptic Filling and QC Laboratory facility project. The role consists in support design and qualifications activities for Facilities, Equipment and Utilities in the frame of site projects. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics as part of this new facility project. You review and/or approve design specifications, layouts, qualification documents, SOPs and take quality decisions according to company standards. This major project is expected to last for the next 5 years and will deliver a next generation manufacturing platform for our fill and finish network.
The activities of the QA Specialist cover all project phases from Basic Design until 1st GMP production in several years. You ensure GMP compliance during Design, Selection, Commissioning and Qualification.
Who you are:
- University or relevant engineering degree
- Hands on experience of qualification/validation in the pharmaceutical industry
- At least 5 years’ experience in a quality environment in pharmaceutical industry or equivalent
- Knowledge in cGMP and health authority expectations
- Experience in Equipment (aseptic fill and finish, isolator technology and support equipment) and qualification
- Experience in tech transfert & quality by design
- Able to address the latest cGMP requirements in engineering projects for sterile drug products.
- Good writing skills, French & English written & spoken.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com