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Gentofte
Would you like to develop further your expertise within IT and Automation Validation in a GMP regulated area? Do you enjoy working in a dynamic and social atmosphere with a strong focus on IT, automation and compliance? If so, we are looking for at IT Validation profile to help us implement new IT solutions and to further optimize our production execution systems and processes.
Apply and joins us today as our new IT Validation Responsible.
The Position
Our projects lie within digitalization and automation solutions, and we need a person to pave the way for all our projects when it comes to validation and compliance. You will be a sparring partner and consultant on smaller projects and a package lead within validation on larger projects.
As an IT Validation Responsible you will keep a good overview of the requirements for implementing IT and automation solutions on both small and large projects.
Key responsibilities
Qualifications
You have a relevant educational background or a strong Pharma / Life Sciences compliance background and experience working with validated computer systems.
To be successful in the role, you have
About the Department
You will be part of a team that secures daily IT and Automation support to four production facilities. The team consists of 20+ competent, openminded and curious IT and Automation Technicians and Engineers. At the same time, we deliver on several small to large projects to these facilities which all are placed in Gentofte. On the organizational level the team belongs to Manufacturing IT, but the team is placed close to production line in the Biotech and Rare Disease production area.
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 app. 2500 colleagues committed to drive 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?
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales.
Contact
For further information, please contact Associate Manager Joachim S. Warberg at +45 30750107.
Deadline
6 November 2022
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.
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Apply and joins us today as our new IT Validation Responsible.
The Position
Our projects lie within digitalization and automation solutions, and we need a person to pave the way for all our projects when it comes to validation and compliance. You will be a sparring partner and consultant on smaller projects and a package lead within validation on larger projects.
As an IT Validation Responsible you will keep a good overview of the requirements for implementing IT and automation solutions on both small and large projects.
Key responsibilities
- Responsibility for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications, Validation Plan/Report, Installation/Operational/Performance and Qualification Protocol/Report
- Working across functions with Quality Assurance, IT, Line of Business and vendors to plan, as well as coordinating and executing computer system validation activities
- Participating in inspections and internal audits
- Performing risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
- Simplifying verification and validation activities including test execution, documentation review and approvals
Qualifications
You have a relevant educational background or a strong Pharma / Life Sciences compliance background and experience working with validated computer systems.
To be successful in the role, you have
- Experience within Azure DevOps, software development, scripted/automated testing
- Previous experience working with global regulatory agencies and authority agencies such as the FDA and MHRA in areas such as, but not limited to, GxP and GAMP framework would be considered advantageous
- Solid project management skills
- Excellent communication skills in English
About the Department
You will be part of a team that secures daily IT and Automation support to four production facilities. The team consists of 20+ competent, openminded and curious IT and Automation Technicians and Engineers. At the same time, we deliver on several small to large projects to these facilities which all are placed in Gentofte. On the organizational level the team belongs to Manufacturing IT, but the team is placed close to production line in the Biotech and Rare Disease production area.
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 app. 2500 colleagues committed to drive 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?
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales.
Contact
For further information, please contact Associate Manager Joachim S. Warberg at +45 30750107.
Deadline
6 November 2022
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.
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Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 21.10.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
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Statistik over udbudte jobs som øvrige i Gentofte
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Statistik over udbudte øvrige i Gentofte over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 5. juli 2024 | 20 |
| 4. juli 2024 | 17 |
| 3. juli 2024 | 18 |
| 2. juli 2024 | 17 |
| 1. juli 2024 | 17 |
| 30. juni 2024 | 20 |
| 29. juni 2024 | 20 |
| 28. juni 2024 | 17 |
| 27. juni 2024 | 20 |
| 26. juni 2024 | 22 |
| 25. juni 2024 | 20 |
| 24. juni 2024 | 20 |
| 23. juni 2024 | 24 |
| 22. juni 2024 | 24 |
| 21. juni 2024 | 21 |
| 20. juni 2024 | 20 |
| 19. juni 2024 | 21 |
| 18. juni 2024 | 20 |
| 17. juni 2024 | 20 |
| 16. juni 2024 | 23 |
| 15. juni 2024 | 23 |
| 14. juni 2024 | 22 |
| 13. juni 2024 | 21 |
| 12. juni 2024 | 22 |
| 11. juni 2024 | 20 |
| 10. juni 2024 | 21 |
| 9. juni 2024 | 24 |
| 8. juni 2024 | 24 |
| 7. juni 2024 | 25 |
| 6. juni 2024 | 23 |
| 5. juni 2024 | 22 |