- Overseeing validation activities in relation to IT for Projects and supporting IT validation of new lines, both locally and worldwide
- Creating Validation and test plans for IT related tasks; approving documentation in collaboration with stakeholders and QA
- Reviewing and overseeing various documents related to validation and qualification to ensure compliance with current GMP rules and guidelines as well as maintaining product quality
- Updating/developing system design documents (Functional Specification, Design Specification for example), Standard Operating Procedures and guidelines for the system operational processes
- Working with incident and deviation management as well as preparation of change requests
- Driving implementation of infrastructure changes and ensuring testing according to requirements We work with various technologies such as SCADA systems and LMES / PAS-X system, and you will be provided with formal and on-the-job training in these technologies. Qualifications
To thrive and succeed in this role, we imagine you have: - At least a bachelor's degree within IT, electronic engineering or any other relevant field
- A great passion for working with IT, system operation and/or automation, as well as a natural curiosity for new technologies and opportunities
- A proven experience with validation and qualification for IT systems or equipment ideally obtained within a manufacturing environment
- Proficiency in English, spoken and written It would be considered as a plus if you have a previous experience in assembly and/or packaging production within a GMP regulated industry (food, dairy, or pharmaceutical industry for example). As a person, you are positive, cooperative and solution oriented. You have a risk-based approach and the ability to balance compliance and product quality. You possess a strong quality mindset and are not afraid of taking charge. Furthermore, you work systematically, logically, and proactively. Last but not least, you thrive in working in a dynamic environment and collaborating with stakeholders from different cultures and organizational levels.
About the department
You will join a highly skilled, experienced and diverse team of 16 IT professionals. We are responsible for areas including IT infrastructure, system management, IT security and digitalization which includes BI & Analytics and AI/ML solutions. In short, all aspects within IT & Digitalization initiatives are driven out of our team. Our manufacturing facility produces a global supply of Injection Pens for insulin and other Novo Nordisk products. We are part of DMS which is overall responsible for the global end-to-end supply chain of Novo Nordisk, both internal and external production via our CMO's (Contract Manufacturing Organisations). We are approximately 700 employees dedicated to ensuring the supply to Novo Nordisk. It's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. At Novo Nordisk, you will find opportunities, resources, and mentorship to grow and build your career. -
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Beskrivelse
Do you have a passion for technical IT and supporting production when a problem occurs? Would you like to be part of our team as we seek a new colleague to help add more fuel to our exciting roadmap ahead? Are you interested in joining us on our ambitious venture, rapidly expanding our production facilities, combined with an ambitious IT business strategy to support this journey? Then this is the position for you Apply today and join our Device Manufacturing & Sourcing (DMS) IT Team based in our production site in Hillerød.
The position
As Senior IT validation Professional, you will be involved in one or more projects, working closely with IT colleagues, QA and stakeholders across DMS to ensure the implementation of new IT solutions and Computerized equipment with the highest quality in mind for the patient.
Your responsibilities will include: