Project Validation Engineer

Project Validation Engineer Are you motivated by working in a changing environment? Does the idea of being involved in a new capacity expansion project where you can influence, and impact future API (Active Pharmaceutical Ingredient) production facilities sounds interesting? Then here is a great opportunity to become a part of a team, where we turn ideas into actions. Apply today for the position as our project validation engineer in a new large green field project. The position
In Biotech & Rare Disease (BRD) we are planning to expand our production facilities in Hillerød, to meet the future need of our expanding product pipeline. As a Project Validation Engineer, you are part of the project quality management (PQM) work package for the newly published API facility. In this role, you have the responsibility to ensure follow-up on quality activities in the different monitoring tools setup from the work package. Furthermore, your role in the team will consist of participating in standardisation of quality related tools, ensuring sufficient quality monitoring during the project, and supporting the new API facility for the license-to-operate. The day-to-day activities related to the role consist of the following (but not limited to):

Supporting work packages with guidance in the project validation concepts

Establishing an overview of validation activities and priorities including the link between multiple project teams (Work Packages)

Supporting in executing commissioning/qualification/validation activities on behalf of a work package

Training in different quality standards used in the project

As a Project Validation Engineer, you will be responsible for ensuring that our commissioning/qualification/validation documentation adheres to Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Qualifications To succeed in this role, you will have:

An academic degree within engineering, natural sciences or similar

+3 years of previous experience with validation projects, and commissioning/qualification/validation in GMP manufacturing

Experience from the pharmaceutical industry

Fluent in spoken and written English

As a professional, you work independently, thrive driving initiatives and have a forward-thinking outlook. As a person, you enjoy collaborating, learning, and sharing information with others. You are driven by achieving great results together with colleagues in a fast-paced environment. You possess excellent communication and collaboration skills enabling you to interact with your many stakeholders from different functions and parts of the organisation.
About the department
Our team is working to expand the Active Pharmaceutical Ingredient (API) capacity of our Biotech production in Hillerød. You will become a part of one of the most significant expansion projects in Novo Nordisk – and when finished the facility will employ app. 340 colleagues. The highly automated facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. It will expand our capacity for our portfolio of clinical late phase products to serve more people living with serious chronic diseases including rare diseases. We do not only drive change for our patients – we also drive life-changing careers for our employees by promoting a learning culture with high levels of trust, innovation, and development throughout the organisation. To drive the project and reach the initial phase of production, we need your help! Are you ready to join the project team and our journey?
Working at BRD, Novo Nordisk
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are more than 3000 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of six state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?
Contact
If you would like to discuss the position further, please feel free to contact our Project Manager, Martin Rosenkjær, at +45 34483248 (available in week 28). Alternatively, you can contact Masood Anwar at +45 81950113 for any questions regarding the application process. Deadline
6 August 2023
Applications will be reviewed on an ongoing basis and so you are encouraged to apply as soon as possible. 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 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. 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.