Senior IT/OT Validation Lead

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Gentofte

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 an IT Validation profile to help us implement new IT solutions and to further optimize our production execution systems and processes. Apply and join us today as our new Senior IT/OT Validation Lead. 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 be a sparring partner and consultant on smaller projects and a package lead within validation on larger projects. As senior IT/OT Validation Lead, you will keep a good overview of the requirements for implementing IT and automation solutions on both small and large projects. Your key responsibilities include:
  • 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 or a strong Pharma / Life Sciences compliance background and experience working with validated computer systems. To be successful in the role, you have:
  • 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
  • Stakeholder management skills
  • Excellent communication skills in English
    • About the Department 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 competencies in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are an app. 2500 colleagues committed to driving change for people with serious chronic diseases. We produce our life-saving medicines out of five 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? Working at Novo Nordisk Founded in Denmark in 1923, Novo Nordisk has become one of the world’s leading healthcare companies. At Novo Nordisk, we are committed to driving change to defeat diabetes and other serious chronic diseases. To fulfil this purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease. That said, we are anything but linear. With us, your skills, commitment, and ambition help us change patients’ lives worldwide. In exchange, we offer you a rewarding and purpose-driven culture with talented and diverse co-workers. Therefore, your professional and personal development is essential for us, and in Novo Nordisk, the sky is the limit for career opportunities Contact For further information, please contact Manager Radoslaw Tyczynski at +45 3075 2982. Deadline June 30, 2023. Applications will be reviewed on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This provides a better and more fair process. 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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    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 16.6.2023, men kan have været deaktiveret og genaktiveret igen.

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