Validation Lead

Category:  Manufacturing
Location: 

Kalundborg, Region Zealand, DK

   

Are you driven by using knowledge and a process-oriented approach to guide and mentor others to succeed? Do you want to be an active part of the development of the world’s state-of-the-art insulin production facility? Do you value being part of a highly skilled team that makes a difference while having fun in their daily work? 

 

Then, apply today and join us for a life-changing career!

 

We are on a very exciting journey of designing and building a monumental state-of-the-art API manufacturing facility on our site in Kalundborg. The position is permanent and offers great opportunities for utilizing and developing your professional skills as well as your personal skills. It also gives you the opportunity to have a significant impact on our new facility while also contributing to improve the lives of millions of people all around the world.

 

The position

As our Validation Lead for API (Active Pharmaceutical Ingredient) in Kalundborg, you will be part of ensuring that our commissioning/qualification/validation documentations comply with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).

 

As our Validation Lead you will be part of a team responsible for:

  • Acting as a validation subject matter expert, ensuring that a science and risk-based validation approach is applied for defining our CQV-strategy
  • Facilitating Risk Assessment workshops
  • Establishing an overview of validation activities and priorities and creating a link between multiple project teams (Work Packages)
  • Facilitating workshops to ensure validation activities are executed effectively.
  • Making sure that internals as well as external stakeholders are properly prepared for validation activities throughout all the phases of relevant projects

 

Qualifications

To succeed in this role, you are:

  • An engineer with a master or PhD degree within natural science or similar, and have a minimum of five years of experience with validation projects
  • A professional with a proven track record of commissioning/validation/qualification experience in GMP manufacturing
  • Experience with project execution is a relevant advantage
  • You can support in translating the needed innovation in the documentation and create conditions for overcoming potential risks and roadblocks
  • Capable of managing multiple stakeholders (external/internal) simultaneously
  • Proficient in English, written and oral. Danish is an advantage but not a mandatory requirement.

 

As a person, you are professional and dedicated by nature. You are proactive, constructive, and full of initiative. You thrive in a challenging, dynamic and ever-changing environment. You have excellent collaboration skills, and in your mind no assignment is too big or too small for you to take on.

 

We are looking for someone with an innovative and solution-oriented mindset. And since you will be working with people from various departments in the organization, you must master the art of collaboration – but also be outgoing and ready to take the lead on discovering and defining opportunities to drive our projects forward.

 

About the department

The position as Validation Lead is placed in the Business Support department in PPV in Kalundborg, which is a part of the global Product Supply division counting about 14,000 employees worldwide. Our department is composed by highly skilled, committed and ambitious colleagues who have a fair bit of fun while delivering high quality standard.

 

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

 

Contact

For further information, please contact André Neves do Amaral +45 3448 1982

 

Deadline

5h of February. Please note that applications are screened on an ongoing basis, so you are encouraged to apply 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.