Senior Technical Engineer

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Gentofte

Are you motivated by the pulse in a production & project department? Do you want to be part of a strong team with high professionalism and challenging processes? Do you want to be a part of the project group implementing and validating our new Isolator filling line in Biotech and Rare Disease production in Gentofte? Then you could be the new Senior Technical Engineer we are looking for. Apply today and join us! The position As the Senior Technical Engineer for the new Isolator filling line, you will play a vital role in the Isolator Filling project, which involves implementing Isolator filling lines in Gentofte. Your expertise will be crucial in ensuring the success of this project and meeting the project's goals and objectives. The job will focus on different tasks and assignments as describing which could be:
  • Conduct rationales and risk assessments to ensure equipment is safe and reliable for the production of pharmaceuticals.
  • Participate in qualification activities such as Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ).
  • Prepare and describe maintenance plans and calibration rationales to guarantee the equipment's longevity and functionality.
  • Assume the Equipment Responsible Role during the project phase and ramp-up period to ensure that the equipment meets the required standards and specifications.
  • Ensure that the filling line equipment maintains a validated state in collaboration with highly skilled and dedicated colleagues, adhering to cGMP requirements for equipment going into production.
    • Collaboration with project members, specialists, pharma consultants, and our vendor is essential in designing and describing processes. You will take the lead in your area of responsibility while working in a supportive team environment. Responsibility for equipment readiness and ensuring that it meets pharmaceutical industry requirements falls under your purview. You will play a crucial role in the Isolator Filling project, leveraging your expert knowledge in validation, qualification, and handling incidents, change requests, and deviations. Problem-solving skills are critical in obtaining document approval and ensuring that solutions align with industry standards. Qualifications To succeed in this role, you will have:
  • Technical Master’s degree or equivalent with minimum 3 years of relevant experience
  • Experience with technically complicated equipment and designing and qualifying equipment according to GMP requirements
  • Familiarity with aseptic production and GMP documentation requirements
  • Proficient in both written and spoken English and Danish
  • Strong technical background and expertise in engineering or related fields.
    • As an individual, you possess a social and positive personality. You are proactive and solution-oriented, naturally inclined to share your knowledge with others. Your systematic approach to work is evident in your commitment to your colleagues and your work. Collaboration and communication come naturally to you, even across professional groups. You excel at managing a high workload without losing sight of the task at hand. About the department Our team is part of the BRD Finished Products Gentofte and Vaarloese area that is the production site situated close to Copenhagen. Here we are app. 725 colleagues who take responsibility for transforming Active Pharmaceutical Ingredients into the finished product that patients can use all over the world. We are producing at full speed on existing lines while building and ramping up new state of the art facilities. Our complex processes require a high level of expertise, commitment, and engagement from our employees and include formulation, filling, freeze-drying, product inspection, assembly and pack. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with LEAN and always looking for improvements within our processes, but also in the way we work together to make our products reach as many patients as possible. Working at BRD, Novo Nordisk Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk 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 more than 3000 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of six 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 also strive 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 For more information, please reach out to our Associate Manager, Henning Hansen, at +45 3079 6321. Deadline 1st of October 2023. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. You are welcome to submit your application in English or Danish. 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 6.7.2023, men kan have været deaktiveret og genaktiveret igen.

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