Operational Responsible for Validation Activities
2 months ago
Would you like to be part of one of Novo Nordisk's expansion projects to increase our API capacity for clinical trials, enabling us to serve more people living with serious chronic diseases globally? Are you motivated by joining a rapidly growing area, where our new API manufacturing pilot facilities continuously requires operational measures, adaptations and validation of our production equipment?
If yes, this is your chance to join our team as Operational Responsible and be part of this exciting journey, which will feature state-of-the-art technology and equipment to establish new processes and products. Apply now and join us for a life-changing career
For an introduction to our area - CMC API Pilots - please visit our career page
The position
To meet the need of our expanding future product pipeline, our new Operational Responsible will be responsible for some of the validation processes and activities in our major investment project, ensuring that the production processes can run on the equipment. This includes e.g.:
Solving both practical and documentation tasks, including the preparation of qualification documents Preparing validation documents in English Running in and performance verification of various equipment (e.g. buffer & process tanks, filtration equipment, chromatography equipment). Delivering input to functional specifications for automationIn this role, you will succeed by being visible, proactive, but also work independently. With your solid process understanding you will interact and create good relationships with our various stakeholders in the project organization, the API pilot facilities, QA, external suppliers and not least other colleagues in the CMC API Pilots area.
This position is based onsite Bagsværd/Denmark.
Qualifications
Our ideal candidate has a science degree such as e.g. M.Sc. scientist or engineer combined with production experience from e.g. pharmaceuticals or subject matter expertise within unit operations such as buffer preparation, precipitation, chromatography, DCF or TFF. Furthermore, it is a clear advantage if you have several years of experience in:
Qualification of equipment according to GMP Project planning of equipment Fluency in written and spoken EnglishWe are looking for a goal-oriented and communicative colleague, who has a high level of initiative and proactive drive as well as a high degree of professional curiosity. The work we do is performed and documented in accordance with GMP, hence it is expected that you have a structural approach to your work and can plan and complete your tasks accordingly.
We also emphasize that you have a good spirit and proactively tackle tasks independently - even when they are not immediately put in front of you. You must be able to handle several tasks at the same time and maintain an overview in stressful situations.
About the department
As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set.
CMC API Pilots manufacture and control new drug substance candidates for the development portfolio at Novo Nordisk . The project department is organised within CMC API Pilots, that will own and operate the new API facilities. We are a department with approx. 100 employees, who are responsible for completing the major investment project to expand our API production capacity for new pharmaceutical candidates for clinical trials in Novo Nordisk.
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