IT Validation Engineer

Job title:

IT Validation Engineer

Company:

Novo Nordisk Foundation

Job description

Are you passionate about IT & digitalization in a life science context. Do you have an excellent track record in planning and strategy execution of qualification and commissioning activities of IT systems or IT Equipment within a Life Sciences context.Then you might be our new IT Validation Engineer in Novo Nordisk Foundation Cellerator, a not-for-profit organisation with the aim of supporting cell therapy candidates.Cellerator will operate in a novel facility which is part of the Novo Nordisk Foundation’s strategic focus areas in the Life science ecosystem. Cellerator aims to be at the forefront of cell therapy technology and engineering. Cellerator will operate as a contract development and manufacturing organisation for cell-based therapies and will be open to academia as well as industry. The project mission is to accelerate the development of cell-based therapy into clinical trials and to establish a new key unit in the cell therapy ecosystem of Denmark and beyond further supporting the strong growth of this field.The job as IT Validation Manager will offer you a unique opportunity to work in a purpose-driven, private foundation with passionate and talented colleagues, who are committed to our vision to improve people’s health and the sustainability of society and the planet. In 2023, the Novo Nordisk Foundation awarded DKK 9.1bn in grants, making it one of the largest philanthropic actors in the world.The Job
The Cellerator laboratory facility is constructed and ready for operation in 2027. We are on the lookout for a candidate who will take ownership both in the project phase and in the following daily operations. You will work closely with the Cellerator team members and related consultants and be executing the digital strategy, ensuring that the company has a native digital foundation for both research and Good Manufacturing Practice purposes.You will be part of an international and purpose-driven working environment with colleagues of diverse backgrounds and perspectives.Your key tasks will include:

• Qualification or commissioning of IT System and IT Equipment.
• Develop and create qualification/commissioning document packages (FAT/SAT, IQ, OQ etc.) and ensuring that these are executed effectively.
• Helping develop and optimize our approach to validation and quality control work and ensure we test and validate the right things at the right level, supporting a risk- based approach.
• Coordinate Qualification activities within the Cellerator team as well as with vendors or integrators.
• Ensure the technical solution adhere to intended use of the IT system or IT equipment.
• Write and review documents, summary reports and other documentation associated with validations or commissioning of systems.
• Ensures systems and processes are validated in a compliant manner in accordance with FDA, EU and Cellerator requirements.
• Assist in the training of and/or direct the efforts of less experienced Engineers and Technicians.

Cellerator currently consists of 11 colleagues with diverse backgrounds and the team will increase during the coming years as part of the implementation strategy before going into operation state.Professional and personal qualifications
Due to the novel nature of the Cellerator, curiosity outside of one’s own area is highly valued, and you should be well known for initiating collaboration between different business areas. You former colleagues still talk about your excellent stakeholder management skills, and they miss working with you due to your ability to create both results and good relationships to the people around you.

We imagine you have a degree within Computer Science, Engineering, Software Development or Experience as IT Validation specialist within Life Science or other highly regulated industries.Further, you have:

• +5 years of experience within IT Validation
• Experience in working with large scale projects.
• Experience with Microsoft Server/Client, MSSQL & Core IT Services like AD/DNS/NTP infrastructure.
• Experience with process equipment integration to Operational Technology systems like Historian, SCADA, LIMS or MES.
• Fluent in English, spoken and written

As the right person for the job, you are ready to take on a steep learning curve by tackling everything from IT system, IT infrastructure and IT equipment qualification or Commissioning activities.Besides being a good colleague, you are:

• Independent and drives decisions on issues relating to cell therapy development and manufacturing.
• Equipped with a profound quality mindset and by nature seek to most simple solution when challenges occur.
• Impact orientated with a risk-based approach to problem-solving.

• You are process-oriented and have good documentation skills
• You are quality minded with good ability to execute within deadlines.
• Have excellent communication and facilitation skill.

Working at the Novo Nordisk Foundation
We offer a committed and professional workplace in which we emphasize ensuring that our colleagues thrive, are challenged, and have opportunities to develop their potential. A career at the Novo Nordisk Foundation, Cellerator gives you the opportunity to work:

• on important projects that improves people’s health and the sustainability of society and the planet.
• with key actors within research and development in Denmark and international;
• and as part of a dedicated team that is passionate about creating impact.

Next step
If you have any questions regarding the position, please contact CEO, Novo Nordisk Foundation Cellerator Thomas Hassing Ronøe Carlsen +45 22 29 56 64 or Senior IT/OT Architect, Novo Nordisk Foundation Cellerator Rasmus Dvinge +45 20 72 63 14.To apply, please send your CV, a short cover letter, university transcripts and other relevant documents by clicking the “Apply now” button no later than 9 June 2024.We are working closely with an external vendor SCI Partners to find the right candidate for the role If you proceed in the process, your CV and application will be shared with them.For GDPR purposes please include in your CV and application that we can share your application and CV with SCI Partners.

Expected salary

Location

København

Job date

Wed, 22 May 2024 22:11:55 GMT

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