Operational Responsible for validation activities

Would you like to be part of one of Novo Nordisk's new projects to expand our capacity for API production to our clinical trials? Are you motivated by joining an area with unparalleled growth, where our new API Pilot facilities continuously require dynamic operational measures, adaptations and validation of our production equipment? This expansion will feature state-of-the-art technology for new processes and products, enabling us to serve more people living with serious chronic diseases.

For the area we are looking for a candidate to join us as Operation Responsible, working closely with our expansion project team. 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

As Operation Responsible, you will take part in the validation activities in our new API Pilot facilities onsite Bagsværd, Denmark. You will participate in and be responsible for:

• delivering input to functional specifications for automation
• running in and performance verification of various equipment (e.g. buffer & process tanks, filtration equipment, chromatography equipment).
• solving both practical and documentation tasks, including the preparation of qualification documents
• preparing validation documents in English

Furthermore, you will have a great opportunity to impact the development and gain solid insight into our workflows and procedures. In 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 pilot facilities, QA, external suppliers and not least other colleagues in the CMC API Pilots area.

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:

• Project planning of equipment
• Qualification of equipment according to GMP
• Fluency in written and spoken English

We 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. 

The project department is organised within CMC API Pilots, that will own and operate the new facilities. We are a department with approx. 90 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. CMC API Pilots is part of CMC (Chemistry, Manufacturing & Control) Development & Scaling manufactures and controls new drug substance candidates for the development portfolio at Novo Nordisk.   

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
If you have any questions, please contact Anette Sikjær Jørgensen on +45 3079 5903 (week 31+32) or Nicolaj Neve on +45 3079 0246 (week 29+32).

Deadline
11 August 2024

You do not need to attach a cover letter to your application, but we encourage you to include a few sentences about why you are applying in your resume or CV.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.