Validation and Compliance Specialist

Category: Project Management & Agile

Location:

Lyngby, Capital Region of Denmark, DK

Are you driven to use your knowledge and experience to help others succeed? Are you ready for a work life where focus is on quality and delivery of life-saving medicines to our patients within intralogistics at our global future Fill & Finish sites?

If yes, then you might be the Validation and Compliance Specialist we are looking for. Apply for this exciting job opportunity at Novo Nordisk!

The Position

Novo Nordisk is investing massively in new production facilities around the globe. With this expansion we will contribute with the important role of producing future products - and you will get an opportunity to be a part of it.

We are seeking a highly skilled and detail-oriented Validation and Compliance Specialist to join our intralogistics team. The ideal candidate will play a critical role in ensuring the validation and compliance of our intralogistics systems, adhering to industry standards and regulations. This individual will work closely with cross-functional teams to develop and execute validation strategies, while also maintaining compliance with relevant guidelines and requirements.

In this role, you will have the following responsibilities:

Develop and implement validation protocols and procedures for intralogistics systems, including material handling equipment, warehouse management systems, and automated storage solutions.

Conduct risk assessments and validation activities in accordance with regulatory requirements.

Collaborate with engineering and operations teams to perform validation testing, analyze results, and address any non-conformities or discrepancies.

Ensure compliance with safety, quality, and environmental standards, while also participating in continuous improvement initiatives to enhance intralogistics processes.

Qualifications

To be successful in this role, we are looking for a candidate with the following qualifications:

Bachelor's degree in engineering, supply chain management, or a related field. A master's degree is preferred.

Proven experience in validation and compliance within intralogistics, logistics, or supply chain operations.

Strong understanding of industry regulations and standards, such as FDA regulations, GAMP guidelines, and ISO 9001.

Excellent analytical and problem-solving skills, with the ability to interpret technical requirements and apply them to validation processes.

Exceptional communication and collaboration abilities, with a keen attention to detail and a commitment to delivering high-quality results.

As a person you are responsible and able to execute necessary decisions to solve the challenges with flair for efficiency and quality. It is important that you thrive in a challenging, dynamic, and changeable environment and no tasks is too big or too small to solve.

Your workplace will be based Lyngby but as there is collaboration required on a global scale with our sites based in Europe, China, and US, some international travel will be required. It is estimated this will be a few days per month. Sometimes you may be travelling for prolonged 1-2 weeks periods. 

About the Department

Fill & Finish Expansions Intralogistics belongs in the newly established Fill & Finish area. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.

You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.

You will refer to Senior manager Martin Ullitz who is an experienced people manager and values a working framework based on mutual trust. He leads through coaching, involvement and empowerment of employees, and psychological safety which creates a healthy learning environment where employees can grow and evolve personally and professionally. 

To learn more about Fill & Finish Expansions in Novo Nordisk visit our career site here: Let's build the future for patients: Exciting Careers in Growing Expansion Project (novonordisk.com)

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 64,000 employees. Together, we go further. Together, we’re life changing.

Contact
For further information you are welcome to contact Martin Ullitz (Senior Manager, FFEx IL) on: +45 3079 7076.

Deadline
10 November 2024.

You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.