Validation Lead

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Do you have a strong drive and excellent quality/validation skills? Do you want to play a key role in defining and leading the validation strategy, to drive efficiency across Novo Nordisk production? If so, you could be our new Validation Lead! What’s in it for you? As the “Distributed Control System” Centre of Excellence Validation Lead (DCS CoE), you will play a crucial role in ensuring the validated state of the system (DeltaV), maintaining compliance with regulatory requirements, and driving continuous improvement through innovative validation and qualification strategies. Your responsibilities will include:
  • Defining and executing validation and qualification strategy for the DCS CoE.

  • Effective communication to build strong relations with colleagues and stakeholders at all levels in the organization, including facilitating workshops, risk assessments and compliance gap analysis.

  • End-to-end validation and qualification activities, including making a validation plan, validation report, Functional specifications, design review, test strategy and execution etc.  

  • Performing various assessments such as Supplier assessment, IT risk assessment, IT requirements risk assessment, functional and data integrity assessments. 

  • Ensuring validated state of the system by performing periodic reviews, addressing deviations, creating and maintaining system documentation and instructions in cooperation with System Managers and IT responsible when needed.  

  • Reviewing and updating of Standard Operation Procedures – setting direction for the validation concept for DCS and training of new employees in both validation concept as well as tools.

  • Ensuring that systems are following relevant internal and external regulatory requirements. The role will also participate in audits and inspections including finding solutions to compliance gaps identified in audits and inspections. 

    • Which competencies to bring?
  • Academic degree within Engineering, Chemistry, Pharmacy, IT or similar.

  • At least 2 years’ experience in any of the following:

  • Technical experience in Computer System Validation (CSV)

  • Manufacturing/production experience or a recognized GMP certificate or qualification.

  • Fluent in written and spoken English, Danish is an advantage.

  • Experience with DeltaV or other automation systems.

    •   As a person, you are known for your pragmatic and solution-oriented mindset, capable of driving continuous improvement within highly complex stakeholder environments. Your effective communication skills enable seamless interaction with both technical and non-technical stakeholders, coupled with the ability to conduct trainings and maintain system documentation. Your strong analytical skills, attention to detail, and structured approach empower you to execute validation plans and test strategies within project timelines. Additionally, your proficiency in mathematics equips you to perform various assessments, making you a well-rounded and valuable candidate for the role. About the Department The department, “Distributed Control System” Centre of Excellence (DCS CoE) is anchored in DD&IT Product Supply. The purpose is to strengthen the Novo Nordisk DCS domain by gathering knowledge, designing standards and providing the best possible team of specialists who support factory operations and run projects around DCS. The department sets direction to ensure processes and projects are optimized.  As part of DCS CoE, you are part of PS Production, working with colleagues across other OT (e.g SCADA) and IT (MES) domains to drive operation and project execution excellence across our global production footprint. Overall, you will join the rapidly evolving and growing Manufacturing IT area, where more than 800 employees are working across the globe to revolutionize IT and OT across our production and supply chain domain in Novo Nordisk. Anchored under Digital, Data and IT (DD&IT) PS Production is the trusted IT partner for production sites and supply chain colleagues worldwide in Novo Nordisk. The team is primarily located in Balleup (Greater Copenhagen area), Denmark and work hand-in-hand with our Product Supply colleagues, meaning that you will get to work closely with the users and technologies that drive our global manufacturing processes to the next level.    Working at Novo Nordisk Novo Nordisk is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that. We are proud of our people too, and we employ more than 60,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change the lives of people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk. Any questions?  For further information, please contact Dorthe Krogh Østerby at +45 3079 2576. Deadline 3 September 2024 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. 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 Ballerup.

    Jobbet er oprettet på vores service den 20.8.2024, men kan have været deaktiveret og genaktiveret igen.

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