Project Validation Engineer
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Hillerød
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? Are you passionate by setting structured standards and experienced in qualification and validation in the pharmaceutical industry? 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 green field project and join us!
The position In Product Supply API we are expanding our production facilities in site Hillerød, to meet the future need of our expanding product pipeline. Therefore, we are looking for a Project Validation Engineer who will becomepart of the executing project quality management (PQM) work package for the API facility. In this role, you are the responsible PQM member attached to a work package (for example Facilities) and must ensure that the work package gets the support as needed and is following the common and described validation approach (GMP and GEP) for the project. 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 approach/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 Furthermore, you will be part of ensuring that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Qualifications To qualify for this role, we expect you to have: A scientific academic degree in engineering, biology, chemistry, or similar. At least 3 years relevant experience within qualification and validation projects in the pharmaceutical industry. Experience with commissioning is an advantage but not a requirement. Experience in cross-functional communication and stakeholder management. A problem-solving mindset, able to manage timeliness and priorities. Full proficiency in spoken and written English.
On a personal level, you possess strong communication skills, with the ability to build relationships and ensure trust and commitment from all stakeholders. You enjoy teamwork and a multicultural environment that demands to also work independently whilst you make decisions that balance quality requirements, authority expectations, and business needs. Personal drive, focus on building structure, implementing improvements and the ability to execute independently and proactively, secures that value is added where it matters within deadlines.
About the department
Our team is working to expand the Active Pharmaceutical Ingredient (API) capacity of our Biotech production in Hillerød. You will become a part of one of the most significant expansion projects in Novo Nordisk – and when finished the facility will employ app. 340 colleagues. The highly automated facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. It will expand our capacity for our portfolio of clinical late phase products to serve more people living with serious chronic diseases including rare diseases. 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. To drive the project and reach the initial phase of production, we need your help! Are you ready to join the project team and our journey? Working at PS API Expansion, Novo Nordisk You will be joining PS API Expansions. The area is anchored in Novo Nordisk Product Supply, Quality & IT, which globally employ approximately 30,000 of Novo Nordisk’s 64,000 employees. PS API Expansions is a newly established and growing area with the responsibility to design, plan and build all major API Expansions projects across Novo Nordisk to serve the needs of millions of patients. We build and design our future API facilities as multi-product facilities with flexibility to accommodate future processes and display state-of-the-art technology and working environment. We focus on delivering the highest quality to patients globally in an efficient and environmentally sustainable way. We are setting the standards for the future, designing facilities we will still be proud of many decades from now. We drive world class execution of capacity projects, and together we are building the future of Novo Nordisk. Contact If you would like to discuss further, you are welcome to contact Project Manager Martin Rosenkjær at +45 34 48 32 48 Deadline
25 August 2024. 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.
The position In Product Supply API we are expanding our production facilities in site Hillerød, to meet the future need of our expanding product pipeline. Therefore, we are looking for a Project Validation Engineer who will becomepart of the executing project quality management (PQM) work package for the API facility. In this role, you are the responsible PQM member attached to a work package (for example Facilities) and must ensure that the work package gets the support as needed and is following the common and described validation approach (GMP and GEP) for the project. 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):
On a personal level, you possess strong communication skills, with the ability to build relationships and ensure trust and commitment from all stakeholders. You enjoy teamwork and a multicultural environment that demands to also work independently whilst you make decisions that balance quality requirements, authority expectations, and business needs. Personal drive, focus on building structure, implementing improvements and the ability to execute independently and proactively, secures that value is added where it matters within deadlines.
About the department
Our team is working to expand the Active Pharmaceutical Ingredient (API) capacity of our Biotech production in Hillerød. You will become a part of one of the most significant expansion projects in Novo Nordisk – and when finished the facility will employ app. 340 colleagues. The highly automated facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. It will expand our capacity for our portfolio of clinical late phase products to serve more people living with serious chronic diseases including rare diseases. 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. To drive the project and reach the initial phase of production, we need your help! Are you ready to join the project team and our journey? Working at PS API Expansion, Novo Nordisk You will be joining PS API Expansions. The area is anchored in Novo Nordisk Product Supply, Quality & IT, which globally employ approximately 30,000 of Novo Nordisk’s 64,000 employees. PS API Expansions is a newly established and growing area with the responsibility to design, plan and build all major API Expansions projects across Novo Nordisk to serve the needs of millions of patients. We build and design our future API facilities as multi-product facilities with flexibility to accommodate future processes and display state-of-the-art technology and working environment. We focus on delivering the highest quality to patients globally in an efficient and environmentally sustainable way. We are setting the standards for the future, designing facilities we will still be proud of many decades from now. We drive world class execution of capacity projects, and together we are building the future of Novo Nordisk. Contact If you would like to discuss further, you are welcome to contact Project Manager Martin Rosenkjær at +45 34 48 32 48 Deadline
25 August 2024. 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.
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 6.8.2024, 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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