Process Engineers for Downstream

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Hillerød

Do you want to be a part of [xxxxx]'s most significant biopharma investment project at site Hillerød aiming at expanding our Active Pharmaceutical Ingredient (API) capacity? Once completed the facility will employ approximately 350 colleagues and feature highly automated and state-of-the-art technologies for new processes and products. Within Downstream processing we have several open positions for both Engineering Responsible and Operational Responsible profiles with different levels of experience. Apply now and join us! The Position In our team we are currently 15 ER’s and OR’s with different backgrounds, experience level and nationalities working together to establish two purification lines. As an Engineering (ER) or Operational Responsible (OR) you will join the project at an exciting time. We have finalized most facility and equipment design and have moved into factory acceptance testing (FAT) in close collaboration with Suppliers and our engineering partners. On site, we are preparing to install process equipment, planning validation activities as well as all activities required for operational readiness. Your key tasks will include:
  • Collaborate with our local engineering partners, your downstream colleagues and ER/OR’s from other discipline areas (automation, upstream, utility, logistics) and Suppliers to agree on equipment, technical, process and automation topics related to manufacturing.
  • Review of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) protocols and reports and participation in FAT and SAT.
  • Develop/give input to protocols for final on-site verification of equipment installation and operation and execute such tests and other validation tests in close collaboration with other downstream team members, CQV-engineers and technical disciplines.
  • Ensuring the facility will be ready for operation by preparing SOPs for production and developing training procedures in collaboration with operators and other users.
  • When the facility has been fully validated and production has started, you will work to ensure stable production of the running manufacturing facility, perform re-qualifications, handle deviations and compliance issues, as well as support operators and maintenance personnel.
    • You will work in collaboration with a wide network of stakeholders. This will include the Work Package Owner (WPO), local production specialists, IT/Automation specialists, other engineering-/operation responsibles, operators as well as engineering partners. Some travel activities must be expected. Qualifications We are looking for both experienced and newly graduated profiles. To succeed in this role, you have:
  • An academic degree within engineering, pharmaceutical science or similar
  • +3 years of experience within life-science industry and working with cGMP. If newly graduated, you have experience with large scale production equipment from your studies.
  • Experience within API production / validation will be a must for the experienced profiles.
  • Full professional proficiency in oral and written English.
    • As a professional, you work independently, take initiative, and have a forward-thinking outlook whilst you trust yourself as a fundamental aspect of effective decision-making. As someone who enjoys collaborating, learning, and sharing information with others, you are driven by achieving great results together with colleagues. Excellent communication and collaboration skills and a positive mindset are essential in this role, making it easier to interact effectively with stakeholders across the organization. Adapting to shifting priorities comes naturally to you, as you will be working in an environment characterized by constant change. About the department We are 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 [xxxxx]. 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, [xxxxx] You will be joining PS API Expansions. The area is anchored in [xxxxx] 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 [xxxxx] 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 [xxxxx]. Contact For further information please contact Manager Helle Baltzer Hattel at +[xxxxx]. Deadline 25 August 2024. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. We do not require a cover letter, but please include a few sentences in your resume or CV about why you are applying. To ensure a fair and efficient recruitment process, please do not include a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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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    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 8.8.2024, men kan have været deaktiveret og genaktiveret igen.

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