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IT System Manager role in CMC Oral Protein Formulation (OPF)

Novo Nordisk A/S

Category: Research Location: Måløv, Capital Region of Denmark, DK

Are you passionate about IT compliance and validation of production equipment? Do you have a strong quality mindset and are you eager to join a department working with processes on the edge of the future? If yes, you could be our new IT system manager

About the department
As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development makes a real difference for patients with chronic diseases across the world. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. The Oral Protein Formulation (OPF) is an area within CMC, which employs approximately 160 highly skilled people organised in four departments and is based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms.

You will join the department - OPF Technical support – which consists of two teams, contributing with a broad range of skills, such as maintenance, calibration, qualification, IT and general support to ensure daily operations. You will be a part of our IT & Quality team. Your team consists of 12 dedicated colleagues maintaining the overall our IT compliance, training and QMS, and we are currently expanding due to increased activity.

The position

As IT system Manager, you will be responsible for the operation and maintenance of several GxP critical IT systems located and used in OPF during their full life-cycle. As equipment and processes are developed and optimized, you need to ensure that all our systems always follow Novo Nordisk’s procedures and external guidelines for computer systems validation (e.g. GAMP) and that we are ready to meet the standards of the future. To achieve that, you:

  • continuously plan and perform validation activities,
  • provide maintenance support to the process IT systems currently used within the area, including user administration,
  • ensure IT security and data integrity.
  • drive implementation of IT system upgrades and new process IT systems.
  • implement IT systems/-solutions together with other IT system managers so as to ensure appropriate test protocols and documentation standards are met.

You will work closely with an IT sub-team - System manager, IT-SME and IT Partner - where teamwork is a key value, and planning and coordination is a must, to be able to succeed in a dynamic environment. Across your tasks and projects, you will also have a close collaboration with stakeholders such as End-users, Project managers, Quality Assurance and Process Groups, but most of all, our team, ensuring that our project timelines and deliverables are met.

You hold a relevant educational background e.g. Bachelor, Masters or equivalent in engineering or IT optimally combined with a few years of relevant working experience, which has given you a solid analytic approach to problem solving. Ideally you have both Knowledge of IT security and networks and knowledge of compliance within IT systems in the pharmaceutical industry as well as experience in supporting, configuring and maintaining such systems.

As a person, you

  • dare to take the lead, even when the task initially is a bit blurry.
  • have a strong quality mind-set in general, and specifically in documentation/validation.
  • enjoy providing daily support within your area of expertise to end-users.
  • like working together with stakeholders of different professions
  • are thorough and find it natural to work independently.
  • Are a good communicator, who shares knowledge to strengthen the overall abilities of our team and you are proficient in both English and Danish or another Scandinavian language.

If you bring a good portion of can-do attitude and humour, we will offer a safe environment, where you can further develop your skills.

For further information, please contact Senior Manager Kenneth Aalbæk Jensen at +45 30753501 or IT System manager Henrik Jakobsen +45 3075 3180

4th of October 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

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Novo Nordisk A/S - hurtigt overblik

Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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