Operational Specialist for Validation Processes

4 weeks ago


Bagsværd, Denmark Novo Nordisk Full time

About the Role

We are seeking an experienced Operational Specialist to join our team in Novo Nordisk's CMC API Pilots department. As an Operational Specialist, you will be responsible for validation processes and activities in our major investment project, ensuring that production processes can run on the equipment.

Key Responsibilities

  • Solving 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 automation

Requirements

  • Science degree such as 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
  • Qualification of equipment according to GMP
  • Project planning of equipment
  • Fluency in written and spoken English

About the Department

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.

Working 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.



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