Working in an international and interdisciplinary team
A versatile role in a young and expanding company
À propos de notre client
Nanomi, based in Oldenzaal, is a drug delivery company developing pharmaceutical products based on nano- and microparticles.
Description du poste
As a Process Engineer you will propose processes to achieve the desired product design, including technical, logistical, SHE procedures. You will select and implement new processing equipment and techniques.
As Process Engineer you will have functional internal contact with engineers, chemists, scientists and project management to exchange information on the full process yielding from pilot to commercial product, its specifications and the midterm planning of the related work. Additionally, you will maintain functional contacts with suppliers and subcontractors to exchange information on equipment and unit operations to further develop the processing techniques to be used in projects company-wide.
- Minimum BSc degree in Process Engineering in Food, Pharma or Medical Devices;
- Substantial experience in mechanical and electrical design, development and construction of aseptic processes;
- Strong analytical skills;
Experience with and knowledge of:
- Experience with cGMP in a commercial pharmaceutical environment;
- Familiar with FDA and EU regulations;
- Experience with CIP/SIP design and cycle development;
- Knowledge of equipment selection and purchasing, setting up URS documents;
- Writing and executing IQ,OQ and PQ documentation;
- FAT/SAT testing;
- Scale-up of processes from lab via clinical to commercial scale;
- Process and instrumentation diagrams;
- Good communication skills - fluent in English, both written as oral;
- Flexible approach to convert general ideas into practical work
- Team player - Pro active - Hands-on - Creativity
Conditions et Avantages
The offer will be according to standards in the pharmaceutical industry. On top of that, you can expect the informal and dynamic environment of a young company. Flexibility and learning, humor and enthusiasm are key aspects in the company culture. We're setting and delivering high quality standards. Development of the company and its people go hand in hand.