Validation Coordinator

Would you like to be part of Novo Nordisk A/S and take part in driving the change in Diabetes?

If you are highly motivated by complex challenges and a broad area of responsibilities within Project Execution Model (PEM) validation and have a keen eye on Quality and Compliance? Then we have an exciting position for you in IM1 Projects, Kalundborg.

This position gives you a great opportunity to influence and develop your own carrier path, as you will hold one of the important roles in the IM1 projects department.

About the department
IM1 Projects is responsible for the investment portfolio and execution of projects in the production facilities. The department is organized in a matrix with approx. 170 colleagues executing the portfolio, consisting of many projects in different phases. We will be driving projects worth more than DKK 500 mio. pr. year during the coming years.

You will be part of the Qualification and Usermanager team consisting of external Quality consultants and internal employees (Engineering and Operational Responsibles). The key part of the job is to ensure validation support to the project organization matrix throughout the PEM-phases.

The position
As a Validation Coordinator you will have a central position in the team and in IM1 projects. You will be a key player and have a daily interaction with Production, Quality Assurance office and other parts of the organizations.

 Your tasks will be diverse and ranging from:

• Ensure that all cross-project disciplines are within the cGMP compliance guidelines
• Build Subject Matter Expert (SME) understanding of the Novo Nordisk Science and Risk-Based Validation (SRV) Procedures
• Be part of technical and validation core process groups and make SME level knowledge available to project groups
• Facilitate Validation training set-up for IM1 employees
• Maintaining up-to-date guidelines and SOP´s
• Translate procedural requirements within validation area into practical workflows guiding the project execution
• Build strong cross-functional relations within Novo Nordisk project organization
• Be part of project planning and coordinating through cLEAN performance culture and board meetings
• Take lead in standardizing the quality workflow ensuring simple and robust transition & handover between project office and production

Qualifications
You have a technical background within Pharmacy, Engineering, Chemistry/Biology or similar. Preferably with +5 years of experience from the Pharmaceutical or Medical Device industry or similar.

• In Novo Nordisk we strive for agility and simplicity in everything we do, so it´s important that you work systematically, logically, and proactively.
• We emphasize on a strong personal profile with can-do attitude, solution oriented, and you find it natural and stimulating when creating new relations to various stakeholders
• It’s important that you can think and act with a broad and strategic perspective, seeing “The Big Picture” without losing sight or interest in important details
• You are robust and capable of handling a, from time to time, high and complex work-pace without losing the overview and motivation
• You are familiar and confident with complex production processes and validation concepts
• Experience with a project organization from a GMP regulated area would be an advantage
• You are proficient in English

Working at Novo Nordisk

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 the communities we operate in.

Contact 
If you want to know more about the position, please contact Associate Manager Tanja Kalstrup at +45 30 79 56 11.

Deadline  

December 10.th, 2023

You can learn more about working at Novo Nordisk A/S by following this introduction website:

https://www.novonordisk.com/careers/working-at-novo-nordisk.html

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.