Job description

To strengthen our R&D team, we are looking for an enthusiastic and motivated Senior Process Engineer who likes to play a leading role in the development of our product and technology platforms. Are you the process engineer who has industrial experience in tech transfer, has a hands-on mentality, and is a team player? Then we are looking for you! Do you want to join our team? Then read further…

The organization

Nanomi is a leader in the field of microsphere and nanoparticle development of long-acting release injectables. The company is located in the green surroundings of Oldenzaal and is a subsidiary of Lupin ltd. The Nanomi team is young and internationally oriented. The working atmosphere is informal and dynamic, with personal development and humor as important pillars.

At the formulation laboratory, small-scale development of microsphere and nanoparticle long-acting release injectables takes place, whereafter the commercial scale is developed in the Process laboratory. As a Senior Process Engineer you will have a leading role in upscaling and ensuring robustness of the developed processes. You will also be responsible for transferring the full commercial scale processes to GMP contract manufacturing organizations (CMO’s) and support manufacturing of GMP productions.

In this leading role of our product development, it is essential to maintain good contact with Project Management, Process and Formulation Engineers and the Analytical team to enable proper alignment within the project team and assure scientifically sound and efficient output.

Responsibilities

As a Senior Process Engineer you:

• Supervise and support lab work activities related to upscaling of processes. Ensure documentation around the work performed is accurate, up-to-date, and according to company standards.
• Independently report outcomes of development studies and identify next development steps.
• Initiate and take the lead in selection, acquisition, and qualification (IQ/OQ/PQ) of custom-made and/or off-the shelf equipment.
• Perform troubleshooting on equipment and initiate corrective actions.
• Seek for continuous process improvement and optimization.
• Take the technical lead in transferring the processes to CMO’s.
• Provide written and verbal update to the technical team and project manager on the project status and progress.
• Ensure compliance to relevant industry standards and GMP regulations.

Functional contacts

In the role of Senior Process Engineer you have functional contacts with:

• Engineers, chemists and technicians.
• Project Management and line management to report on technical progress and experimental planning.
• Suppliers, CMO’s and other subcontractors on technical aspects.

Profile

• Knowledge: comparable to MSc in a relevant field like Chemical Engineering, Process Engineering, Mechanical Engineering, or related disciplines.
• Experience: at least 5 years of industrial experience. GMP experience and aseptic manufacturing is a highly preferred.
• Skills: Flexible approach converting general ideas into practical work. Writing skills at MSc level. Knowledge about tech transfer, GMP regulations and industry standards.
• Competences: Problem solving, result oriented, pro-active, communicative team player, hands on mentality and critical thinking.

Interested? Please contact us! We are happy to receive your CV and motivation letter