Environmental Monitoring Specialist for expanding aseptic production

Indrykket: 17.6.2020

Novo Nordisk, Kalundborg

  • Manufacturing
  • Kalundborg

Do you have the knowledge and know-how to enter a role where you will be the main source of expertise in all aseptic production environment-related issues? Are you ready to be the person who guides and drives compliance initiatives, validation processes and optimisation projects with solid structure and energising communication? Then please consider being a part of an ambitious department on an exciting journey that you can play a major part in, with all the opportunities for personal and professional development we can offer in our truly global organisation.

About the department

In Biopharm Finished Products (FP) in Kalundborg, we handle products that help people live with chronical diseases like heamophilea, hormone imbalances and growth disorders. We ensure that our quality products are made ready for use by transforming large batches of precisely formulated substrates into consumable pen-fills and vials, ready for packing and distrubution to virtually all parts of the world. This is done in our filling lines, where our dedicated colleagues handle impressively large numbers of units daily in a tighty regulated aseptic production environment, that obviously needs to be in total compliance with the strictest quality standards.

In Aseptic Production Support, where we support these activities by handling deviations, validating changes in equipment and processes and much more, we share an informal tone, a well-established trust in each others capabilities and we truly enjoy both sharing knowledge, ideas and challenges – and cake. You will join 113 colleagues in our effort to pursue perfection, most of us with technical or scientific backgrounds.

The position

Overall, your responsibilities as our new specialist in Environmental Monitoring (EM) will be to ensure alignment with guidelines in the EM area, while driving and guiding various initiatives to improve and optimise processes and setups. This obviously takes on many shapes and forms – and your close and effective collaboration with a host of stakeholders with many different concerns and circumstances will be key to your success – many people will come to you every day for deep dives into a range of setups, regulations and processes, and you have to be ready to provide them with the knowledge that ensures their tasks and projects progress as planned.

Technically, you will carry the overall responsibility for SOP content, validation processes and regulatory approvement, GMP behaviour and compliance with EM standards throughout the aseptic production facility. As a member of the process group, you will be working with important parts of the workday for most of your collegues like gowning procedures, hygeine tasks and aseptic techniques and behavior as a whole.

Sometimes you will be acting as an important second line of support, if any issues around EM are identified or suspected. Your input may have a profound impact on how we do things, and it is important that you back all of your decisions with data and thorough analysis, while maintaining the ability to provide quick answers when needed.

Qualifications

We expect you to have earned your MSc. a while back and gathered quite a bit of experience since then. It is of lesser consequence whether you have your background in engineering, chemistry or have worked your way here as a pharmacist or microbiologist. Most importantly, you possess the knowledge within Environmental Monitoring, aseptic production and classification, and the interpersonal skills that allow you to fill this demanding role responsibly. You know the landscape of cleaning and hygeine processes well and recognise the value in precise documentation.

People will tell us that you energise your surroundings, and that your natural authority and your ability to communicate your expectations clearly have been a major part of the successes you will demonstrate to us. Also, it will be obvious to us that you have capable knowledge of at least some of the filling processes we work with, or from a similar setup.

Your lucid command of both English and Danish allow you to communicate effortlessly at all technical and organisational levels.

About Novo Nordisk Kalundborg

Become a part of Novo Nordisk Manufacturing in Kalundborg and get a developing career among the most talented people in a successful company. Together, we make a real difference every day for more than 30 million people living with diabetes and other chronic diseases.

We have 50 years of expertise in biotechnological production at Novo Nordisk in Kalundborg. Generations of employees have developed their professional qualifications, personal skills and careers at Novo Nordisk and have helped develop the production facility to become the largest insulin-producing facility in the world.

Today, our 3,000 employees produce half of the world’s insulin and a number of biopharmaceutical products. Furthermore, our finished product sections assemble and pack diabetes and biopharmaceutical products.

You will soon sense why Novo Nordisk Kalundborg is a highly unique place and why we are passionate about working here. You will be met with trust and responsibility by welcoming and dedicated colleagues. Novo Nordisk Kalundborg is a workplace where involvement, development and multidisciplinarity are in focus.

Contact

If you wish to learn more about the position, the department or how we do things here, please feel free to call Anders Nielsen at +45 30 75 94 40.

If you want to learn more about what it is like to work in Novo Nordisk, this may be a good place for you to begin: https://www.novonordisk.com/careers/working-at-novo-nordisk.html

Deadline

2 august 2020
Kontaktoplysninger Klik for yderligere info: Se annoncen hos Novo Nordisk...
Ansøgningsfrist Søndag den 02. august 2020
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic diseases.

Novo Nordisk is a global healthcare company with more than 95 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 diseases: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 80 countries and markets its products in more than 170 countries.