This is your opportunity to be involved in a newly created team from the very beginning and use your knowledge, experience and commitment to create results. We are looking for a new colleague for an academic position in 1T Pilot Support Team in the Chemistry & Purification department. The department is part of CMC API Production in R&D. 1T Pilot Plants purify proteins for use in toxicological and clinical studies. Overall responsibility of the team is to plan and support campaign production of Active Pharmaceutical Ingredients (API’s) in three pilot plants on the basis of requests from Novo Nordisk's development projects within the diabetes area. An important prerequisite for the successful production of campaigns is to secure that plants are in GMP compliance regarding qualification of equipment and documentation. As well as to fulfil the external environment and the working environment requirements, those issues are therefore an essential part of the team responsibilities.
The 1T Pilot Support Team, consists of a total of 11 employees and is a part of a larger department with 43 employees split in 3 teams, and the 1T Pilot Support team is formed recently as a result of restructuring the teams. We offer an exciting position, where you will be part of ensuring timely delivery of API to clinical studies in close cooperation with the colleagues.
Combine your experience within unit operations and chemistryYou will be part of the preparation and execution of campaigns in the Pilot Plants as well as ensuring release of the product for clinical studies. Another important part of you responsibility will be to ensure support to the Operations Team, trouble shooting, coordination of qualification tasks and user responsibility in smaller facility projects. You will contribute to identification and implementation of continuous improvements with the purpose of achieving a stable and efficient production.
You help to ensure GMP compliance in 1T Pilot Plants, including equipment qualification, preparation and implementation of necessary standard operating procedures (SOP’s) and ensure that we follow the SOP’s covering our functional area.
The tasks will be carried out in very close cooperation with our stakeholders, including Technical Support, Development Laboratories, Analysis Laboratories, Quality Assurance, as well as the rest of the Chemistry & Purification Department.
Experienced engineer from GMP environmentYou have a MSc in Engineering (Chemistry/mechanical) or similar and years of experience within pilot or full scale production in a GMP environment, preferably purification of proteins. Project management skills and experience is an advantage. You enjoy working in a pilot production and have experience within process engineering, unit operations and process control systems. You are good at coordinating tasks or minor projects. On a personal level, you enjoy working in a flexible and dynamic environment and we expect you to be ready to embrace changes and to have a quality-mindset. We consider it important that you are extrovert and good at cooperating with colleagues across your organization. You are ambitious and ready to take responsibility of many different tasks.
We offer an exciting and varied job in an open and dynamic work environment with good opportunity for professional and personal development.
ContactFor further information, please contact Connie Langberg Heinze on +45 3079 2205 or Annette Jörgensen on +45 3075 2570.
Please mark your application "NN48420 - Engineer for 1T Pilot Plants in Bagsværd".
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