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Senior Process Engineer
- Process Engineer
- Mechanical and Electrical Design
Over onze klant
Nanomi, based in Oldenzaal, is a drug delivery company developing pharmaceutical products based on nano- as well as microparticles. These particles are developed by using Nanomi's microfluidic Monosphere Technology, enabling the manufacturing of very unique and uniform custom-made particles for a broad range of pharmaceutical products. In 2014 Nanomi was acquired by Lupin and became its center of excellence for complex injectables. Nanomi offers a highly innovative as well as dynamic environment and benefits from its parent company that was founded in 1968.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 5th and the 7th largest generics pharmaceutical company by market capitalisation and sales globally (March 31st, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.68% market share - IMS Health, National Prescription Audit, March 2016); the 3rd largest Indian pharmaceutical company by revenues; the 6th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).
Taken en verantwoordelijkheden
As a Senior Process Engineer you will develop and implement new process methods and techniques to be used in the manufacturing process of complex injectable microspheres. You will propose processes to achieve the desired product design, including technical, logistical and Safety, Health & Environment (SHE) procedures. One of your main responsibilities is developing and implementing new processing methods yielding the final product. Therefore, you will select and implement new processing equipment and techniques.
You will work in a team of nine other Process Engineers and report directly to the Head of Process Development. We are looking for creative and proactive candidates, who have a flexible approach and can convert general ideas into practical work.
Responsibilities include but are not limited to:
- Assist in setting Quality Control (QC) product specifications from the perspective of the capability of certain production processes;
- Check and report whether process controls and observations are conform expectations;
- Functional internal contact with engineers, chemists, scientists and project management to exchange information on the full process yielding the pilot/pivotal/commercial product, its specifications and the midterm planning of the related work;
- 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.
- A minimum of a BSc degree in process engineering (or similar) in life sciences (food, pharma, medical devices);
- Experience in mechanical and electrical design, development and construction of aseptic processes;
- Knowledge of equipment selection;
- Knowledge of cGMP and FDA regulations;
- Experience in CIP/SIP design and cycle development;
- Writing experimental protocols, standard operating procedures (SOP's) and batch records is a plus;
- Excellent communicator with a fluency in English (verbal and written);
- Team player, strong analytical skills and hands-on;
- One year contract with the intention for extension to an indefinite contract;
- Very competitive salary;
- Attractive secondary benefits;
- Interesting opportunities for career progression.