Validation Responsible
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Do you have experience within Manufacturing Execution Systems (MES), or with validation of processes, equipment, or IT systems for pharmaceutical production? Are you passionate about data, technology, and digitalization? If yes, you might be our new colleague.
Apply today and become part of the Manufacturing Development Packaging department!
The position
In this job, you will be responsible for validating and the continuous improvement of our master batch records in PAS-X, thereby optimizing the digitalization of our manufacturing processes.
Among other tasks you will:
• Have the responsibility of implementing and validating the new and improved digital solutions.
• Ensure the creation and update of master data and assist in systemic troubleshooting before, during, and after production.
• Be part of building and maintaining a robust digital foundation.
• Be responsible for increasing the department knowledge about our MES system, e.g. through training and communication about the changes and updates you make.
• Ensure the future in MES use for development process.
Moreover, you will be responsible for the prioritizing among, and implementation of new and improved solutions based on project needs and inputs from the MES users (manufacturing supporters, technicians, and operators) in order to ensure that we are ready for production of new development products as well as ensuring that our clinical productions are running smoothly.
In your daily work, you will have many stakeholders across the organization including production, development, business support, IT, and QA. Your working day will be versatile, and your tasks will have short as well as long deadlines.
Qualifications
In order to succeed in this role, you:
• have a relevant academic background, e.g., software-, mechanical-, chemical, or production engineering, or other relevant education.
• have experience with MES as a consultant, developer, superuser, or have experience with validation of systems.
• have experience from GxP regulated production environment.
• It is an advantage if you have worked with PAS-X and/or SAP and worked with the validation of systems, master data or pharmaceutical manufacturing. But the most important is your drive, for ensuring that the optimal digital process is in place.
• Full proficiency in English. On a personal level you are good at keeping the overview and enjoy collaboration with several stakeholders. You possess good communication skills, and thrive in a dynamic environment; you are comfortable with a high pace, and you have a positive can-do attitude.
The department
The department is part of Emerging Technologies Oral Product development (ET OPDev)
We are involved in primary packaging of tablets for clinical phase I-III trials, as well as preparation of packaging processes for many exciting new products a part of packaging for the submitting process.
Preparing for new products is a significant part of our responsibility and will become more important in our daily work. The department consists of an operator/technician team, a support team, and an equipment team. We package on a blister and as well as on a bottle line. You will be part of the support team. In the coming years, we will be implementing at least two new packaging lines, a blister and a bottle line. At the same time, we will be moving to a new building, which means that we are currently working on projects. It is a big and exciting task, so our daily work is anything but boring. As responsible for the MES system validation, you will be a big part of the new projects.
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 – we’re all working to move the needle on patient care.
Contact
If you have any questions about the position, please contact Manager Trine Jakobsen at +45 34 48 11 55
Deadline
14 Februrary, 2024. We invite candidates for interviews on an ongoing basis and will close the advertisement as soon as we have found the right candidate.
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.
Apply today and become part of the Manufacturing Development Packaging department!
The position
In this job, you will be responsible for validating and the continuous improvement of our master batch records in PAS-X, thereby optimizing the digitalization of our manufacturing processes.
Among other tasks you will:
• Have the responsibility of implementing and validating the new and improved digital solutions.
• Ensure the creation and update of master data and assist in systemic troubleshooting before, during, and after production.
• Be part of building and maintaining a robust digital foundation.
• Be responsible for increasing the department knowledge about our MES system, e.g. through training and communication about the changes and updates you make.
• Ensure the future in MES use for development process.
Moreover, you will be responsible for the prioritizing among, and implementation of new and improved solutions based on project needs and inputs from the MES users (manufacturing supporters, technicians, and operators) in order to ensure that we are ready for production of new development products as well as ensuring that our clinical productions are running smoothly.
In your daily work, you will have many stakeholders across the organization including production, development, business support, IT, and QA. Your working day will be versatile, and your tasks will have short as well as long deadlines.
Qualifications
In order to succeed in this role, you:
• have a relevant academic background, e.g., software-, mechanical-, chemical, or production engineering, or other relevant education.
• have experience with MES as a consultant, developer, superuser, or have experience with validation of systems.
• have experience from GxP regulated production environment.
• It is an advantage if you have worked with PAS-X and/or SAP and worked with the validation of systems, master data or pharmaceutical manufacturing. But the most important is your drive, for ensuring that the optimal digital process is in place.
• Full proficiency in English. On a personal level you are good at keeping the overview and enjoy collaboration with several stakeholders. You possess good communication skills, and thrive in a dynamic environment; you are comfortable with a high pace, and you have a positive can-do attitude.
The department
The department is part of Emerging Technologies Oral Product development (ET OPDev)
We are involved in primary packaging of tablets for clinical phase I-III trials, as well as preparation of packaging processes for many exciting new products a part of packaging for the submitting process.
Preparing for new products is a significant part of our responsibility and will become more important in our daily work. The department consists of an operator/technician team, a support team, and an equipment team. We package on a blister and as well as on a bottle line. You will be part of the support team. In the coming years, we will be implementing at least two new packaging lines, a blister and a bottle line. At the same time, we will be moving to a new building, which means that we are currently working on projects. It is a big and exciting task, so our daily work is anything but boring. As responsible for the MES system validation, you will be a big part of the new projects.
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 – we’re all working to move the needle on patient care.
Contact
If you have any questions about the position, please contact Manager Trine Jakobsen at +45 34 48 11 55
Deadline
14 Februrary, 2024. We invite candidates for interviews on an ongoing basis and will close the advertisement as soon as we have found the right candidate.
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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 15.12.2023, 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
- Måløv
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