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Qualification/HVAC Pilot Scientist for CMC Oral Protein Formulation (OPF)

Novo Nordisk A/S



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

Are you passionate about compliance and qualification of production equipment/HVAC? Are you eager to join a department working with processes on the edge of the future? If yes, you are the Qualification/HVAC Pilot Scientist that we are looking for.

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 Facility & Equipment team. Your team consists of 13 dedicated colleagues, with a broad range of skills, all contributing to sustain our “License to operate”, and we are currently expanding due to increased activity.

The position
As Qualification Scientist, your primary focus will be performing validation/qualification of facilities including HVAC/BMS/FMS and equipment for GMP use and support to process optimisation. A vital part of your job is to ensure that we are following GMP standards as well as implementing development equipment. Your tasks will cover activities such as supplier contact to qualification/ implementation of equipment/facilities, handover to end user, change request and deviation handling.

You will play a key role in our business-critical efforts to ensure and maintain the facility’s license to operate. Across your tasks and projects, you will therefore 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.

Qualifications
You:

  • have a Bachelor’s or Master degree within Engineering or Pharmacy
  • have minimum 3 years of experience with qualification/validation/GMP of production equipment in the pharmaceutical industry and/or experience with HVAC, FMS and BMS
  • are proficient in written as well as spoken Danish and English.

Knowledge within solid dosage forms may be an advantage but it’s not a prerequisite

On a personal level, you:

  • Are a good communicator, who shares knowledge to strengthen the overall abilities of our team. 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.
  • Dare to take the lead, even when the task initially is a bit blurry.
  • Have a good approach to structure, when it comes to planning and executing on tasks.

We look forward to welcome you, in our team!

Contact
For further information, please contact Senior Manager, Kenneth Aalbæk Jensen at +45 30753501 or Senior qualification scientist Pernille Ringgaard +45 30775331

Deadline
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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