IT System Manager

4 weeks ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time
About the Role

We are seeking an experienced IT System Manager to join our Aseptic Pilot Plant team in Chemistry, Manufacturing, and Control (CMC). As a key member of our IT sub-team, you will be responsible for driving the implementation of IT system upgrades and new process IT systems, optimizing IT operations, and collaborating in digitalization projects.

Key Responsibilities

  • Drive the implementation of IT system upgrades and new process IT systems
  • Optimize IT operations and collaborate in digitalization projects
  • Provide maintenance support to the process IT, including user administration
  • Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes

Requirements

  • Ideal candidate has a relevant academic background or technical background/technical interest in working close with the production
  • Relevant experience within GMP and validation is seen as an advantage, but a newly graduate with a GMP certification/course can also be considered
  • Experience or interest within pharmaceutical Quality Management, or participation in GxP system validation and a desire to grow in the profession
  • Possess knowledge of IT security, networks, and compliance within IT systems
  • Proficiency in both spoken and written English and Danish

About the Department

Aseptic Pilot Plant is part of CMC and responsible for production of new aseptic medicinal products for clinical studies, primarily for phase 1 and 2. We are approx. 85 employees divided in 4 teams, who work together to maintain all functions in the aseptic facility. APP covers the responsibilities, wash and sterilisation, preparation, filling, inspection, utility, environmental monitoring, cleaning, maintenance, and validation.

In your daily tasks you will collaborate with mechanics, operators, technicians, chemists, and engineers who work determined towards delivering products for our customers and for the development projects in the right quality at the right time.

We work on day shift and our department is well-functioning and productive. It should be fun to go to work, and for us a healthy working environment is a must. Together, we will ensure that you immediately feel welcome around your new colleagues, who love to share their knowledge and always take care of each other.

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