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Facility Coordinator for Oral pilot and process development

  • Research
  • Denmark - Måløv

Are you motivated by securing the operation of HVAC/FMS/BMS systems in our facility and running small-scale projects? Can you picture yourself shaping a newly established role as Facility Coordinator? If yes, then this might be just the right role for you.

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. Our ambition is to develop break-through products based on orally available versions of GLP-1 and other proteins. We are a business area with great attention and thus expanding which is why we are looking for a new Facility Coordinator.

About the department
We are 51 colleagues, who are responsible for formulation, process development and manufacturing of oral protein products for preclinical and clinical trials in our Pilot Production Plant and at Contract Manufacturing Organisations (CMOs). We have our own pilot facility spanning approximately 650 m2 with 3 development and production lines covering a broad and exciting range of process technologies for solid dosage forms. We are responsible for technical support, project management and execution related to qualification of equipment, utilities and facility.

Team Facility Support, which you will be a part of, ensures that the facility and equipment at all times are ready for production, both for development and GMP purpose. We have a broad spectre of responsibilities within our facility such as monitoring HVAC/FMS/BMS systems, securing IT and equipment qualifications and validations, performing calibrations and maintenance as well as training and Quality Management System (QMS).

The position
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 internal and external stakeholders such as local in house Project Managers, Quality Assurance and Process Groups, ensuring that our facility project time lines and deliverables are met.

This is a unique possibility of entering into a newly re-established role where you can be part of shaping the area of responsibilities. In cooperation with your colleagues, your main area of responsibility will be to ensure that the facility is running as planned all year, including system monitoring on HVAC, BMS, FMS and live up to cGMP standards. You will handle minor projects, non-conformities, change requests as well as SOP updates to ensure at high quality facility at all times.

During closedowns, you will be responsible for planning and reporting of the closedown and ensuring a smooth and timely closedown, where you make sure that all projects/tasks are coordinated and handled within the agreed deadlines. In other words you will have a crucial responsibility in securing that the facility runs smoothly throughout the year cycle.

Qualifications
You hold a relevant academic degree on minimum bachelor level, preferably within Engineering.

Further, you have some experience with operating HVAC/BMS/FMS systems and have knowledge about change requests, reporting and handling of non-conformities. It is an advantage but not a prerequisite that you possess Project Manager experience.

You have a strong quality mind-set to mitigate the right quality level without complicating the way we work. You have the ability and interest in making plans, structuring and ensuring progress on tasks and handling a broad stake-holder landscape. You are self-driven and possess the energy to make things happen and taking the necessary initiatives within your area of expertise. You thrive in a changeable environment in a dynamic team.

Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Tonny Jessen at +45 3075 7409 or Henrik Tesch Iversen at +45 3075 8001.

Deadline
2 April 2018.

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