MES Validation Responsible
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Do you have a passion for validation in a GMP and development environment, and the ability to differentiate between the two? Do you also have excellent communication skills with stakeholders, and the ability to quickly adapt to changes? If yes, we want you to be a part of our MES team at Novo Nordisk! Apply today! The position In this role, you'll have the chance to plan validation activities, support production, and perform risk-based validation of systems and infrastructure. You'll also collaborate with the IT department to plan and execute MES system activities, ensuring best practices for validation are followed. With a team of 16 colleagues, you'll be working together to validate production processes for large-scale production. You will be a part of a MES (PAS-X) group with responsibility of supporting production in relation to continuous improvement of MES-system and validation of MES design for new products for clinical production.
Among other tasks you will:
• Work collaboratively with IT department to plan, coordinate, and execute MES system activities.
• 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.
You will be the interface between the IT organisation and production, ensuring that we follow best practices for validation. 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
To succeed in this role, you: • Have a Master’s degree engineering or natural science, or a Bachelors’ with extensive experience
• Experience with validation in a GMP regulated environment is considered a strong advantage, but newly graduates are also welcome to apply.
• Ability to learn MES systems.
• Are fully proficient in English
• Experience with PAS-X is considered an advantage.
The ideal candidate should be a team player, possess a can-do attitude and be self-driven, proactive, and responsible. You should be able to communicate effectively with stakeholders, bringing your ideas to the table and facilitating healthy discussions. You should also be comfortable giving and receiving feedback, and always be willing to challenge the status quo. Our business environment is dynamic and subject to frequent changes, so you should be comfortable collaborating closely with stakeholders to ensure our business processes remain agile and responsive to change.
The department The department is part of Emerging Technologies Oral Finished Products.
We are involved in production of tablets for clinical phase III, as well as preparation of production processes for many exciting new products.
Preparing for new products for clinical phase III is a significant part of our responsibility and will become more important in our daily work. The department consists of two operator/technician teams, two support teams, and an equipment team. You will be part of one of the support teams. As responsible for the MES system validation, you will be a big part of the new projects. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact For further information, please contact Cecilie Drobek Mejdahl at [email protected] Deadline
14 January, but we are reviewing candidates on an ongoing basis.
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.
Among other tasks you will:
• Work collaboratively with IT department to plan, coordinate, and execute MES system activities.
• 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.
You will be the interface between the IT organisation and production, ensuring that we follow best practices for validation. 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
To succeed in this role, you: • Have a Master’s degree engineering or natural science, or a Bachelors’ with extensive experience
• Experience with validation in a GMP regulated environment is considered a strong advantage, but newly graduates are also welcome to apply.
• Ability to learn MES systems.
• Are fully proficient in English
• Experience with PAS-X is considered an advantage.
The ideal candidate should be a team player, possess a can-do attitude and be self-driven, proactive, and responsible. You should be able to communicate effectively with stakeholders, bringing your ideas to the table and facilitating healthy discussions. You should also be comfortable giving and receiving feedback, and always be willing to challenge the status quo. Our business environment is dynamic and subject to frequent changes, so you should be comfortable collaborating closely with stakeholders to ensure our business processes remain agile and responsive to change.
The department The department is part of Emerging Technologies Oral Finished Products.
We are involved in production of tablets for clinical phase III, as well as preparation of production processes for many exciting new products.
Preparing for new products for clinical phase III is a significant part of our responsibility and will become more important in our daily work. The department consists of two operator/technician teams, two support teams, and an equipment team. You will be part of one of the support teams. As responsible for the MES system validation, you will be a big part of the new projects. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact For further information, please contact Cecilie Drobek Mejdahl at [email protected] Deadline
14 January, but we are reviewing candidates on an ongoing basis.
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 19.12.2023, 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.
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