Validation Specialist

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Hillerød

Are you an experienced Validation Specialist, Validation Engineer or Validation Lead ready to embark on your next opportunity? Are you eager to share your knowledge of manufacturing processes validation to support our production capacity expansion? Could your experience in defining validation strategies, within pharmaceutical industry, set the direction for validation, with a focus on robust processes and product quality? If these questions piqued your interest, then grab this one-of-a-kind opportunity today and apply for the Validation Specialist position in our Assembly team within Device Manufacturing Development department. Waiting for you at site Hillerød is a truly international team and a string of challenges that will keep you motivated in the long run. The position As our Validation Specialist you will be responsible for defining and executing device assembly validation activities across multiple geographical locations, to set the direction for continuous improvement of science and risk-based validation, and to mentor colleagues in validation. You will become a key member of the projects and you will:
  • Manage and contribute to validation activities of the project, from basic design and establishing User Requirement Specification (URS) through to process risk assessment and validation (PV) of new production lines.
  • Take part in driving the standardisation and Lean agendas within validation when implementing multiple lines at different sites to ensure that they conform with our corporate risk-based validation approach.
  • Be engaged in innovative validation practices, such as remote Factory Acceptance Test (FAT), leveraging validation activities and implementation of ongoing process verification.
    • In return, you can look forward to a rich professional experience with strong collaboration with multiple stakeholders from Corporate to local sites, R&D, Production, Suppliers, Quality Assurance (QA) and other specialists in multiple domains. There would also be some travel opportunities. Qualifications For this role, we are looking forward to connecting with candidates who:
  • Have a minimum of 8-10 years of experience as Process or Validation Engineer within a regulated industry (pharmaceutical, medical devices, food…) and understanding of science and technical aspects of the manufacturing processes,
  • Hold at least a MSc degree in process engineering, pharmacy, or any other relevant field,
  • Have a strong quality mindset combined with experience within drug or device development,
  • Have expert knowledge and hands-on experience with quality risk management and validation in medical device manufacturing,
  • Are fluent in English (both written and spoken) and experienced with MS Office 365, Teams, e-TIMS and other relevant software solutions.
    • Who are you as a person? Although we try not to place people in boxes, there are some traits that we believe will help you thrive in this role. You are ideally well organised, someone who never compromises on quality and have a pragmatic approach in your work. As innovative thinker, you are willing to act as lead in our Lean activities and to challenge the status quo. Patience, strong communicative aptitudes, and stellar stakeholder management skills will help you deal with the local sites and their practices. It is essential that you are a true team-player at heart: you like to collaborate with colleagues and stakeholders in order to achieve common goals. As a specialist, it is also expected that you will act as a role model for your highly skilled colleagues and that you are ready to support the people around you. About the department You will join Device Manufacturing Development (DMD) and the Assembly department. We are a key function, bridging Device R&D to production. We are involved in the development of new devices, and responsible of the development and implementation of manufacturing capacity worldwide for new and marketed products. Our belief is that a diverse workforce directly supports our goal to provide the highest-quality work: we are almost 40 different nationalities in DMD right now, coming from different levels of experience and educational backgrounds. The Assembly department, located in Hillerød, includes 50+ highly engaged skilled professionals from project managers, specialists, validation, process, and science experts. We are collaborating with multiple stakeholders and striving for excellence in project execution, science engineering, innovation, and technology. Working at Novo Nordisk At Novo Nordisk, 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 For further information, contact Thomas Algot Søllested at +45 3079 7725, or Ariane Giguere-Robert at +45-34483236. Deadline 30 July 2023. Please note that applications will be reviewed, and interviews will be scheduled on an ongoing basis. 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 Hillerød.

    Jobbet er oprettet på vores service den 16.3.2023, men kan have været deaktiveret og genaktiveret igen.

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