Project Validation Engineer
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Hillerød
Are you motivated by working in a changing environment? Does the idea of being involved in a new capacity expansion project where you can influence, and impact future API (Active Pharmaceutical Ingredient) production facilities sounds interesting? Then here is a great opportunity to become a part of a team, where we turn ideas into actions. Apply today for the position as our project validation engineer in a new large green field project.The position
In Biotech & Rare Disease (BRD) we are planning to expand our production facilities in Hillerød, to meet the future need of our expanding product pipeline. Therefore, we are looking for a project validation engineer. As a Project Validation Engineer, you are part of the executing project quality management (PQM) work package for the newly published API facility in Hillerød.
In this role, you are the responsible PQM member attached a work package (for example Clean Utilities) and must ensure that the work package gets the support as needed and is following the described validation approach (GMP and GEP). Furthermore, your role in the team will consist of participating in standardisation of quality related tools, ensuring sufficient quality monitoring during the project and supporting the new API facility for the license-to-operate.The day-to-day activities related to the role consist of the following (but not limited to):Support work packages with guidance in the project validation concepts. Establishing an overview of validation activities and priorities including the link between multiple project teams (Work Packages) Supporting in executing commissioning/qualification/validation activities on behalf of a work package Training in different quality standards used in the project. As a Project Validation Engineer, you will be part of ensuring that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
QualificationsTo suceed in this role, you have:An engineering or academic degree in natural sciences or similar. +3 years experience with validation projects, and commissioning/qualification/validation in GMP manufacturing Thrives in a fast-paced environment with many concurrent tasks. Fluent in spoken and written English
As a professional you are working independently, you thrive driving initiatives and have a forward-thinking outlook. As a person, you enjoy collaborating, learning and sharing information with others. You are driven by achieving great results together with colleagues. You possess excellent communication and collaboration skills enabling you to interact with your many stakeholders from different functions and parts of the organisation.About the department
Join us at 25L API Capacity Expansion and become a part of one of ’s most significant expansion projects, embedded in Biotech & Rare Disease (BRD). In BRD, we are building a new API production facility in Hillerød that will employ around 340 colleagues. The highly automated production facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. We manufacture through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from our employees and including cultivation, recovery, purification and freeze-drying. It will also expand our portfolio of clinical late phase products and increase our capacity to serve more people living with rare disease and serious chronic diseases.
To drive the project and reach the initial phase of production, we need your support. We do not only drive change for our patients – we also drive life-changing careers for our employees by promoting a learning culture with high levels of trust, innovation and development throughout the organisation. Are you ready to join the project team and our journey?
Working at
Working at BRD is part of Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all 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 are also stiving 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
If you would like to discuss further, you are welcome to contact Project Manager Martin Rosenkjær at +
Deadline
14th of April 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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.
In Biotech & Rare Disease (BRD) we are planning to expand our production facilities in Hillerød, to meet the future need of our expanding product pipeline. Therefore, we are looking for a project validation engineer. As a Project Validation Engineer, you are part of the executing project quality management (PQM) work package for the newly published API facility in Hillerød.
In this role, you are the responsible PQM member attached a work package (for example Clean Utilities) and must ensure that the work package gets the support as needed and is following the described validation approach (GMP and GEP). Furthermore, your role in the team will consist of participating in standardisation of quality related tools, ensuring sufficient quality monitoring during the project and supporting the new API facility for the license-to-operate.The day-to-day activities related to the role consist of the following (but not limited to):
QualificationsTo suceed in this role, you have:
As a professional you are working independently, you thrive driving initiatives and have a forward-thinking outlook. As a person, you enjoy collaborating, learning and sharing information with others. You are driven by achieving great results together with colleagues. You possess excellent communication and collaboration skills enabling you to interact with your many stakeholders from different functions and parts of the organisation.About the department
Join us at 25L API Capacity Expansion and become a part of one of ’s most significant expansion projects, embedded in Biotech & Rare Disease (BRD). In BRD, we are building a new API production facility in Hillerød that will employ around 340 colleagues. The highly automated production facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. We manufacture through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from our employees and including cultivation, recovery, purification and freeze-drying. It will also expand our portfolio of clinical late phase products and increase our capacity to serve more people living with rare disease and serious chronic diseases.
To drive the project and reach the initial phase of production, we need your support. We do not only drive change for our patients – we also drive life-changing careers for our employees by promoting a learning culture with high levels of trust, innovation and development throughout the organisation. Are you ready to join the project team and our journey?
Working at
Working at BRD is part of Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all 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 are also stiving 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
If you would like to discuss further, you are welcome to contact Project Manager Martin Rosenkjær at +
Deadline
14th of April 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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 "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 31.10.2023, 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.
- Projektleder
- Hillerød
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