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Engineer - Cleaning Validation Responsible

2 weeks ago

Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

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Location:

Bagsværd, Capital Region of Denmark, DK

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 require operational measures, adaptations, and validation of our production equipment?

Then join us to play a key role in ensuring equipment cleaning validation in our multi-purpose facilities. 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 Cleaning Responsible will be responsible for the validation of the automated CIP (Cleaning In Place) equipment, processes, and procedures. The cleaning responsible will work across two facilities covering both fermentation and recovery. The equipment has been designed and is now ready for the equipment validation activities and process descriptions. This exciting opportunity will give you valuable experience in major investment projects as well as with cleaning strategies, fully automated cleaning equipment, and cleaning validation activities. This includes:

  • Define and ensure compliance with the cleaning strategies for the facilities
  • Set the direction for equipment cleaning in our new facilities
  • Solve practical and documentation tasks, including the preparation of qualification documents
  • Preparing, planning, executing and reporting cleaning validations
  • Delivering input to functional specifications for automation
  • Running in and performance verification of the CIP equipment
  • Testing and validating novel in-line analytical methods with potential to benefit across Novo Nordisk production sites.

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, external suppliers, QA, and not least other colleagues in the CMC API Pilots area as well as other cleaning responsible across Novo Nordisk.

This position is based onsite in Bagsværd, Denmark.

Qualifications

Our ideal candidate has a science degree such as M.Sc. scientist or engineer combined with several years of cleaning and production experience from the pharmaceutical industry. Furthermore, it is a clear advantage if you have experience in:

  • Cleaning validation of equipment according to GMP
  • Project planning of equipment qualification and validation
  • 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 hectic 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 more than 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.

Contact

For further information, please contact Senior Manager, Anne Krogh Rovik, at +45-30776312.

Deadline

April 15, 2025.

Please note that applications will be reviewed continuously. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To facilitate an unbiased 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 the communities we operate in. Together, we're life changing.

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