Operational Responsible for Validation Activities

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Would you like to be part of one of [xxxxx]'s expansion projects to increase our API capacity for clinical trials, enabling us to serve more people living with serious chronic diseases globally? Are you motivated by joining a rapidly growing area, where our new API manufacturing pilot facilities continuously requires operational measures, adaptations and validation of our production equipment? If yes, this is your chance to join our team as Operational Responsible and be part of this exciting journey, which will feature state-of-the-art technology and equipment to establish new processes and products. Apply now and join us for a life-changing career! For an introduction to our area - CMC API Pilots - please visit our career page The position To meet the need of our expanding future product pipeline, our new Operational Responsible will be responsible for some of the validation processes and activities in our major investment project, ensuring that the production processes can run on the equipment. This includes e.g.:
  • Solving both practical and documentation tasks, including the preparation of qualification documents
  • Preparing validation documents in English
  • Running in and performance verification of various equipment (e.g. buffer & process tanks, filtration equipment, chromatography equipment).
  • Delivering input to functional specifications for automation
    • In this role, you will succeed by being visible, proactive, but also work independently. With your solid process understanding you will interact and create good relationships with our various stakeholders in the project organization, the API pilot facilities, QA, external suppliers and not least other colleagues in the CMC API Pilots area. This position is based onsite Bagsværd/Denmark. Qualifications Our ideal candidate has a science degree such as e.g. M.Sc. scientist or engineer combined with production experience from e.g. pharmaceuticals or subject matter expertise within unit operations such as buffer preparation, precipitation, chromatography, DCF or TFF. Furthermore, it is a clear advantage if you have several years of experience in:
  • Qualification of equipment according to GMP
  • Project planning of equipment
  • Fluency in written and spoken English
    • We are looking for a goal-oriented and communicative colleague, who has a high level of initiative and proactive drive as well as a high degree of professional curiosity. The work we do is performed and documented in accordance with GMP, hence it is expected that you have a structural approach to your work and can plan and complete your tasks accordingly. We also emphasize that you have a good spirit and proactively tackle tasks independently - even when they are not immediately put in front of you. You must be able to handle several tasks at the same time and maintain an overview in stressful situations. About the department As part of [xxxxx] PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. CMC API Pilots manufacture and control new drug substance candidates for the development portfolio at [xxxxx] . The project department is organised within CMC API Pilots, that will own and operate the new API facilities. We are a department with approx. 100 employees, who are responsible for completing the major investment project to expand our API production capacity for new pharmaceutical candidates for clinical trials in [xxxxx]. Working at [xxxxx] At [xxxxx], 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, please contact Nicolaj Neve (Specialist) on +[xxxxx]or Anne Krogh Rovik (Manager) on +[xxxxx]. Deadline
    6 November 2024 You do not need to attach a cover letter to your application, but we encourage you to 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 [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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 17.10.2024, men kan have været deaktiveret og genaktiveret igen.

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