Validation Engineer

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Hillerød

Would you like to develop further your expertise within IT and Automation Validation in a GMP regulated area? Do you enjoy working in a dynamic and social atmosphere with a strong focus on IT, automation and compliance? If so, we are looking for a new colleague to help us implement new expansion projects transferring from single product to a multipurpose facility? Apply now for Validation Engineer role and join us for a life-changing career with the purpose of making a difference for people living with haemophilia and other rare disorders. The Position Our projects lie within digitalization and automation solutions, and we need a person to pave the way for all our projects when it comes to validation and compliance. You will keep a good overview of the requirements for implementing the solutions and be a validation sparring partner on both small and larger projects. Your key responsibilities summed up:
  • Responsibility for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications, Validation Plan/Report, installation/Operational/Performance and Qualification Protocol/Report
  • Working across functions with Quality Assurance, IT, Line of Business and vendors to plan, as well as coordinating and executing computer system validation activities
  • Participating in inspections and internal audits
  • Performing risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
  • Simplifying verification and validation activities including test execution, documentation review and approvals.
    • Qualifications
  • You have a relevant educational background and experience from compliance and/or validation project implementing IT/OT solutions in the Pharmaceutical Industry
  • You offer a solid technical understanding of manufacturing equipment with insight into GMP, validation and computerised equipment
  • You understand interfaces between systems, as well as human and machine interaction and can build a bridge between the needs of your colleagues and automated solutions
  • Solid project management skills
  • Fluent in written and spoken English.
    • Previous experience working with global regulatory agencies and authority agencies such as the FDA and MHRA in areas such as, but not limited to, GxP and GAMP framework would be considered advantageous. About the Department You will join the automation team with 10 skilled and very committed colleagues, growing into 20 during 2023, organisational placed in Manufacturing IT operating in 25K to support BRD API production where we partner with production. Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in 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. 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-don't hesitate to get in touch with Martin Ruban Leleur, Associate Manager at +45 3077 5954. Deadline April 9, 2023. Applications will be reviewed, and interviews scheduled on an ongoing basis, so please do not hesitate to apply. 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 to 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 13.2.2023, men kan have været deaktiveret og genaktiveret igen.

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