Manufacturing Specialist API

Category:  Manufacturing
Location: 

Hillerød, Capital Region of Denmark, DK

   

Do you have a strong technical background and experience with validation in a GMP regulated environment? Are you energized by using this knowledge to guide and mentor others to succeed? Do you thrive on solving complex equipment tasks such as optimisation, validation, and project planning of new facilities? Would you like to be part of a highly skilled production unit dedicated to make a difference for people living with Haemophilia? Then we’d like to hear from you. Apply today and join us in Hillerød for a life-changing career.  

 

The position

As Manufacturing Specialist API in Biotech and Rare Disease API Facilities (BRD) you will be overall responsible for ensuring that our equipment and environment complies with GMP and ISO regulations and ensuring optimisation of production equipment performance. You will undertake solving of complex equipment and environmental relevant tasks such as optimisation, validation, and project planning.

 

You will set the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (incl. calibration and maintenance strategy approach). You will be responsible for the daily guidance of employees working with qualification of equipment and processes and ensure that tasks are solved at the right level. You will provide technical instruction and supervision of engineers and technicians, hereunder be responsible for on-going training of employees in cGMP and will play a key role in GMP related activities.

 

Our production unit consists of three departments: Facilities, Production and New Product Entry & IT. You will be reporting to the department manager of the Facilities department and will be working closely with specialists and other stakeholders in the two other departments. The Facilities department consists of three teams: Equipment, Maintenance and Environment, which you will all be supporting.

 

Qualifications

To succeed in this role, you have:

 

  • An engineering, masters, or PhD degree within natural science or similar
  • Solid technical experience within the pharma industry and general experience with production and/or development of pharmaceutical products
  • Proven track record of validation/qualification experience in GMP manufacturing or CMC process development in the pharmaceutical, biotechnology or similar industry
  • In-depth knowledge of cGMP and business processes
  • Fully proficient in both written and spoken English

 

On a personal level, you feel empowered by guiding and mentoring employees and making them succeed. You have role model behaviour and feel comfortable giving and receiving feedback in an open and respectful way that fosters personal growth. You possess strong analytical skills combined with an in-depth business knowledge. Furthermore, you value close collaboration and have a natural and strong ability to navigate in a complex stakeholder landscape at all levels.

 

You can keep a cool head and make decisions in a busy work environment where the agenda changes frequently. We expect you to have excellent interpersonal skills and problem-solving skills.

    

About the department

You will be part of a dynamic business area under Biotech and Rare Disease API DK, which produce Active Pharmaceutical Ingredients (API) for Haemophilia patients across the world. The Facilities department is responsible for maintaining existing production equipment and implementing new equipment in the facility. We are situated in Hillerød and we currently produce Refixia® and Mim8 which are used to treat haemophilia patients. During the coming years we will embark on an exciting journey to include additional new products into our facility, thus becoming a multi-product facility.

 

Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe.

 

Not only are we making a difference for patients – we are also stiving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone.

 

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. 

 

Contact

For further information, please contact Senior Manager Sabine Blicher Lerche Kruse at +45 3079 8443.

 

Deadline

31 July 2022. Please note that we will conduct interviews on an ongoing basis, so please submit your application as soon as possible.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.