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Transportation validation expert

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Novo Nordisk A/S

Hillerød, 1 stilling

- Engineering
- Denmark - Hillerød

Are you eager to draw attention to your profound project manager skills and provide transportation solution to future pharmaceuticals? This is your chance to bring your personal ambition and passion to work and to take tomorrow’s transportation solutions to the next level

About the department
You will join a dedicated and highly competent team in Device Manufacturing and Development. Our field of responsibility is to develop transport solutions for intermediate products and finished products, validate equipment for internal- and external cold chain transport and support all manufacturing units with heat studies on packaging- and assembly manufacturing lines. The team works closely with all manufacturing units and the Shipping and Supply Chain Planning department.

The job
As Validation responsible, you perform transport process validation, e.g. ensuring quality and compliance when transporting Novo Nordisk’s products in a challenging and unforeseeable environment. In particular, it is your responsibility to make protocols, to coordinate tests and document in reports that the products stay within the specific standards of tolerance from the moment they leave the ramp at Novo Nordisk until they reach the final destination. Together with the carriers and other suppliers, you have the responsibility for documenting equipment qualification and its compliance with the regulation e.g. EU GDP and local legal requirements. Additionally, you produce validation documentation within shipping that supports strategic new product registration in various countries. You also play a key role in preparing and presenting validation documents for Danish and international authorities, and you participate in the audits and inspections, giving a detailed account of the validation methods and the results. The position offers you a unique opportunity to take on an independent job, where you can leave your mark on the department while realising your goals and seeing the benefits of your work in global environment.

You have combined your Master’s degree in engineering, Pharmacy or another relevant educational background with 5+ years of experience from a comparable position within pharmaceutical products, Good Distribution Practise or process support. You have a proven track record in GMP and risk analysis expertise and have successfully worked with validation. You have a systematic, analytical and thorough approach to your work and you are keen on finding sustainable solutions. You have a sense of initiative and enjoy an independent role where you work as the go-to-person who possesses solid in-depth expertise within your field of work. This job also requires excellent communication and cooperation skills, as you navigate your way around colleagues, foreign authorities and other stakeholders, and balance support and continuous follow-up. Finally, you take pride in meeting your deadlines and you never compromise on quality in your work.

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.

For further information, please call Erik Ethelfeld on +45 3075 6106.

8 November 2015.