Experienced EM Project Professional

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Gentofte

Are you driven by the opportunity of gaining a professional development by being responsible for tasks where the knowledge and standards will elevate as the projects progresses? Do you want to make an impact and be the one responsible for the microbiological environment in our new isolators? Then it is you, we are looking for in our project position! The position Environmental monitoring (EM) is one of the most important controls in clean areas and provides meaningful information on the quality of the environment for aseptic processing. As EM project chemist, you will be a part of the project process support team and responsible for securing, defining, and establishing microbiological monitoring inside our isolator filling lines and being our microbiological monitoring go to person. It is expected that the successful candidate will:
  • Define the microbiological sample locations based on rationales for worst-case locations.

  • Write rationales and other necessary documentation for implementing environmental monitoring before and during production of aseptic products according to GMP.

  • Be accountable for EM performance verification of grade A isolators to document that the environment is in control.

  • Collaborate closely with colleagues to solve tasks and find the right solutions.

  • Responsibility for a specific area but work together with colleagues to achieve goals.

    • If you are a self-motivated individual who values collaboration and is solution-oriented, with a passion for driving and executing complex projects, you can be an essential member of this team. You will have the opportunity to contribute to the development of projects where environmental stability is a critical component. QualificationsTo succeed in this role, you have:
  • Master's degree in natural science, e.g., M. Sc. Pharm, M. Sc. Microbiology, or other relevant areas.

  • 2+ years of experience in microbiology in an aseptic pharmaceutical production area with isolator and EM knowledge.

  • Quality mindset and experience working in a highly regulated GMP environment in the pharmaceutical industry.

  • Proactive and solution-oriented mindset when solving tasks.

  • Full professional proficiency in English.

    • You should possess strong organizational and structural skills to effectively manage tasks, projects, and work-related activities. As a candidate for this position, you will be expected to manage stakeholders effectively, communicate clearly and concisely, and be proactive in your approach to work and problem-solving. You should always be looking for ways to improve processes, workflows, and outcomes and be able to think creatively and outside of the box to identify and solve complex problems. 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 further information, please contact Associate Manager, Rebecca Rink Disch at +45 30795270 Deadline Apply before July, 31 2023. 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 7.7.2023, men kan have været deaktiveret og genaktiveret igen.

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