Denmark Job Openings
Novo Nordisk
Validation Specialist
Hillerød
September 16, 2024
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.
- 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.
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.
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.
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.
For further information, please contact Senior Manager, Hans Kristian Rømer Westh, at +45 30796795.
6 October 2024.
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