Validation Specialist

Validation Specialist to integrate new IT systems and technologies into productive processes Do you have an experience in validation requirements for IT and equipment in pharmaceutical processes to make sure that new IT systems and new technologies are integrated into production processes in compliance with GMP requirements? Are you motivated by learning new requirements to apply them to new implementations? Are you excited about a hands-on approach to creating documents, executing valuation activities, and teaching new colleagues your vast knowledge? Do you like to work in an environment where new technological solutions are developed to bring the greatest business value to the organization? Then we might have the right job opportunity for you, as we are looking for a Validation Specialist to join the Novo Nordisk BRD Digital & Projects organization. The position
As our new Validation Specialist, your main task will be to develop and support the development of the validation approach and documentation to integrate new IT systems and new technologies such as robots, machine learning models and any other technologies to our production lines and any other GMP entity. Supporting the development teams since the first stages of the development phase to ensure that the right path is taken to enable the solution to be scaled up afterward. The scope of the position includes preparation of validation documentation, validation test execution, and participation in workshops for requirements discussion. It is important that you can navigate throughout GMP validation requirements for IT and equipment as well as NN requirements in order to make sure that only the necessary and sufficient is done related to the validation strategy. You will also be encouraged to take the lead on increasing the department’s level of maturity in scientific and risk-based validation approaches and to continuously improve our processes and way of working smarter. You will use your interpersonal skills to challenge the status quo while focusing on solutions and opportunities and you will contribute to a continuous high professional passion and engagement within the team.
Qualifications
You hold an academic degree in Engineering, Chemistry, Pharmacy, IT, or similar. We expect that you have at least 5 years of work experience within a pharmaceutical production process and validation of IT systems where you have acquired knowledge of IT/equipment validations and how to navigate in a GMP-regulated environment. An interest and knowledge of digitalization and new technologies.

You care for details in your work without losing your general view, and you have strong analytical skills. Moreover, you have a strong command of English allowing you to prepare documentation in a fluent technical language.

As a person, you are known for your open attitude and for taking a proactive approach to challenges.

Stakeholder management and working cross-functionally and globally.

About the department You will be part of the BRD Project Execution team in the Digital & Projects department within our Manufacturing Development area. The main responsibility for the team is to lead investment projects across Product Supply BRD in Denmark and we are focused on expanding our investments in facilities and equipment. BRD Digital & Projects is part of BRD Manufacturing Development & Quality Control which has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio.
Our team, BRD Enterprise IT Projects is part of the BRD Manufacturing Development Digital & Projects department which has its base in Gentofte, Denmark. Our aim is to increase the value generation to our Line of business through a continuous improvement of our Digital Solutions. The main responsibilities of the department are supporting and optimizing all parts of the production using automation and simulation, from the manufacturing of active pharmaceutical ingredients all the way to finished products. BRD Digital & Projects is part of BRD Manufacturing Development & Quality Control which has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio.
Working at BRD, Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life-changing. 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 competencies in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are approximately 2500 colleagues committed to driving change for people with serious chronic diseases. We produce our life-saving medicines out of five 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
For further information, please contact Juliana Cecília Cunha (JCUN) +45 3448 0213 Deadline 28.02.2023