Operational Specialist for Process Validation Initiatives

2 weeks ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Novo Nordisk A/S is expanding its API capacity for clinical trials, and we are looking for an Operational Responsible to join our team in this exciting project.

The role will involve operational measures, adaptations, and validation of production equipment to establish new processes and products.

The successful candidate will have a strong understanding of GMP and process validation, as well as experience in qualification of equipment, project planning, and fluency in written and spoken English.

We are looking for a goal-oriented and communicative colleague with a high level of initiative and proactive drive, who can work independently and handle multiple tasks simultaneously.

About the department:

CMP API Pilots manufacture and control new drug substance candidates for the development portfolio at Novo Nordisk. The project department is organized within CMC API Pilots, which will own and operate the new API facilities.

We are a department with approximately 100 employees, responsible for completing the major investment project to expand our API production capacity for new pharmaceutical candidates for clinical trials in Novo Nordisk.

The position is based onsite in Bagsværd/Denmark, and the ideal candidate will have a science degree, e.g., M.Sc. scientist or engineer, combined with production experience from pharmaceuticals or subject matter expertise within unit operations such as buffer preparation, precipitation, chromatography, DCF, or TFF. Additional requirements include qualification of equipment according to GMP, project planning of equipment, and fluency in written and spoken English.

We are looking for a candidate with a structural approach to work, who can plan and complete tasks accordingly, and has a good spirit and can proactively tackle tasks independently, even when they are not immediately put in front of them.

We prioritize a "can do" mind-set and a strong team culture in our organization.



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