Project Validation Engineer

3 weeks ago

Hillerød, Denmark Novo Nordisk AS Full time

Are you interested in playing a pivotal role in a new capacity expansion project that will shape the future of API (Active Pharmaceutical Ingredient) production facilities? Do you have a passion for establishing structured standards and a proven track record in qualification and validation within the pharmaceutical industry? If so, this is your opportunity to join our team as a Project Validation Engineer in a green field project. Apply today


The Position

As a Project Validation Engineer (PVE), you will be an integral part of the executing project quality management (PQM) work package for the API facility in our expanding production facilities at site Hillerød. Your responsibilities will include ensuring that the work package receives the necessary support and follows the prescribed validation approach (GMP and GEP) for the project. Additionally, you will be involved in standardizing quality-related tools, monitoring quality during the project, and supporting the new API facility to obtain the license to operate.

In this capacity, you will play a pivotal role in assisting work package owners (WPOs) with various commissioning, qualification, and validation (CQV) activities. This will involve ensuring correct documentation, adherence to established standards, and facilitating the seamless execution of these critical activities to meet project objectives.

The PQM team comprises several experienced and skilled Validation Project Engineers, each overseeing specific areas such as upstream or downstream processes, as well as dedicated document controllers.

In addition, you will:

  • Work closely with various stakeholders and be actively involved in a range of validation activities in CQV.
  • Be expected to thrive in a dynamic environment with competing priorities, requiring proactive engagement with diverse stakeholders to ensure project success.


Qualifications

To excel in this role, we expect you to have:

  • A scientific academic degree in engineering, pharmacy, chemistry, or a related field.
  • At least 2 years of relevant experience in qualification and validation projects in the pharmaceutical industry, preferably within science and risked-based validation (SRV).
  • Proficiency in cross-functional communication and stakeholder management.
  • A problem-solving mindset, capable of managing timeliness and priorities.
  • Full proficiency in spoken and written English.


About the department
Join our team at 25L PS API Expansion, one of Novo Nordisk's major expansion projects within Product Supply API. We're establishing a cutting-edge API production facility in Hillerød, set to employ around 340 colleagues. This highly automated facility will feature state-of-the-art technology, allowing for flexibility to accommodate new processes and products. Our work involves complex chemical and biotechnological processes, demanding a high level of expertise, commitment, and engagement from our employees, covering cultivation, recovery, purification, and freeze-drying. This expansion will enhance our portfolio of clinical late phase products and bolster our capacity to support individuals affected by rare and serious chronic conditions.


Working at Novo Nordisk Site Hillerød
At Novo Nordisk Site Hillerød, we are around 4,000 employees developing, producing, and filling injection pens to help patients around the world living with serious chronic diseases, such as diabetes and obesity. Here we also house a large factory dedicated to the production of life-saving medicine for patients with rare diseases.

At Site Hillerød we employ a diverse range of talent working across the value chain, and we are growing fast. In fact, we are one of the most rapidly expanding sites in Denmark. For this reason, we have many exciting job opportunities and therefore we are continuously looking for new talented colleagues. Join us and become a part of extraordinary teams implementing new technologies to take our production to new heights and serve even more patients.

The site is located in beautiful surroundings and offers good transportation options from Copenhagen, Hillerød, and the rest of North Zealand.


Contact :
If you would like to discuss the role further, please contact Associate Manager, Masoud Hosseini, at


Deadline
22 December, 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.

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.

#J-18808-Ljbffr

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