Validation Specialist

Location:

Hillerød – Frederiksborg, Zealand, Denmark

Salary:

Competitive

Type:

Permanent

Main Industry:

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Advertising, Marketing & PR, Education & Training, Engineering Health, Nursing & Social Services, Information Technology, Legal, Purchasing & Supply Chain, Science

Job ID:

131108194

Posted On:

17 September 2024

   

Are you experienced in validation of Finished Product processes within the pharmaceutical industry and ready to lean processes and set global strategic direction? Do you thrive on collaborating in a complex and diverse stakeholder landscape and are you committed to delivering stellar results?
If so, this is the perfect role for you. Join us as a Validation Specialist in Device Manufacturing Development (DMD), Assembly & Packaging Strategic Support. Apply today for a life-changing career!

The Position
As Validation Specialist in our Strategic Support unit, you will be setting and safeguarding the strategic direction for lean and standardized validation in a wide portfolio of global capacity projects within the processes of Assembly and Packaging of Novo Nordisk Finished Products. The role involves close collaboration with central organizations in Novo Nordisk as well as a large portfolio of project teams in DMD. 

Your key tasks entail:
•    Setting and safeguarding the strategic direction for lean and standardized validation within a wide portfolio of global capacity projects within the processes of Assembly and Packaging.
•    Driving development, implementation and maintenance of document standards and validation templates with NN process, from Science- and Risk-based approach to validation, in line with the Fill & Finish Expansion (FFEx) Quality strategy.
•    Close collaboration, communication, and stakeholder management with a wide audience of global stakeholders, program organizations and specialists at all levels.

Qualifications
To be successful in this role, we expect you to have:
•    An academic degree in Engineering, Pharmaceutical Science or other relevant field.
•    Hands-on experience in validation within the pharmaceutical or medical devices industry, and preferably a good insight into Finished Products production.
•    In-depth knowledge within regulatory requirements for validation, including drug, combination, and device products (EU GMP Annex 15, IMDRF, MDSAP, 21 CFR part 820, 21CFR part 11,  21 CFR part 211).
•    Fluency in English, both written and spoken.

On a personal level, you possess strong communication skills and seamlessly connect with stakeholders. You excel in navigating diverse perspective and orchestrating decisions that align with the best interest of everyone involved. You are not just a team player but also an inspiration, transforming challenging into opportunities for the team’s and business’ success.

About the Department
You will join DMD strategic support for Assembly and Packaging departments, a cross-organisational function supporting Novo Nordisk Finished Manufacturing Development of pen injectors and tablets. We are bridging product development to production and driving development and standardization of new, smarter, and aligned processes.
Furthermore, we are responsible for establishing assembly and packaging capacity worldwide for new and marketed products in compliance with current regulatory requirements and in close interaction with the Novo Nordisk global production sites. We have an end-to-end presence from device development to production implementation and support to running production.
We are mainly located in Hillerød and our department is growing rapidly, consisting of employees placed into different teams and physical locations. At the office, we share an informal tone, great work morale and tall ambitions to be the best at what we do. Once you step into this role, you will join a diligent and highly competent team and be at the crossroad between Device and Delivery Solutions, Quality, and Production.

Working at FPM, Novo Nordisk
Finished Product Manufacturing (FPM) is a part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality production of pharmaceutical products. At FPM, we not only manufacture all finished products for people living with serious chronic diseases, we also use our competencies to drive technology leadership and improve standards across our core technologies to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.
Our global network consists of around 6,000 colleagues across ten countries. Here, we are responsible for the manufacturing of all finished products, including devices, needles, assembly, and packaging. As more and more people need our products, we support Novo Nordisk’s initiatives in new therapy areas. Every day, we strive to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.

Contact
For further information, Senior Manager, Hans Kristian Rømer Westh, at +45 30796795.

Deadline
6 October 2024.

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 to 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.

 

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