IT Validation Specialist

4 weeks ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

At Novo Nordisk Digital Data & IT, we're on a mission to unlock the full potential of data towards helping more patients worldwide. It's an ambitious mission that requires many bright minds to succeed.

Are you driven by the desire to ensure the integrity of IT systems through rigorous validation processes? Are you enthusiastic about driving validation of IT Systems and Computerized Equipment, bringing our IT landscape to the next level and scaling it up to match our new strategy?

We invite you to apply for the position of IT Validation Lead in Delivery & Guidance Services department within Product Supply Data Foundation area.

The Position

As an IT Validation Lead, you will be a key player in a dynamic team that delivers digital solutions for complex processes. Your primary role will be to define and execute validation and qualification strategies for GxP and non-GxP Computerized Systems both in the project and operation phase.

Your main responsibilities include:

  • Drive and execute validation and qualification strategy, including making a Validation plan, Validation report, Design Review, Test strategy and execution etc.
  • Conduct diverse assessments including Supplier, IT risk, IT requirements risk, and functional and data integrity assessments
  • Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel to create and update system documentation and instructions as necessary
  • Ensuring that systems are following relevant internal and external regulatory requirements, including finding solutions to compliance gaps identified in audits and inspections.
  • Foster strong relationships with colleagues and stakeholders through effective communication, including workshops and risk assessments.

We are looking for

An ambitious and proactive colleague who can contribute to the team both professionally and personally. To succeed in the role, you have a proven track record in most of the following:

  • B.Sc. within Engineering, Chemistry, Pharmacy, IT or similar.
  • Extensive and proven experience in one of the two: Computer System Validation (CSV) or manufacturing/production experience with recognized GMP certificate/qualification.
  • Strong knowledge of IT GxP validation, preferably in a regulated industry such as pharma or healthcare. Relevant certifications such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC
  • Have experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.
  • You should have excellent communication skills and be able to effectively communicate with stakeholders, team members, and management. You should be able to articulate compliance requirements and validation strategy and provide guidance on best practices.

On a personal level, you are passionate, self-organised, a team player, and strive for continuous improvement. You have the ability to ensure a healthy, engaging, and inclusive work environment.

The team waiting for you

You will be part of Delivery & Guidance Services department within PS Data Foundation, who is responsible for continuously developing, scaling, and maintaining global production data platforms. These data platforms are designed to efficiently extract and standardize data from both production lines and IT/OT systems used in production processes. In Data Foundation, we strive to empower our colleagues in Novo Nordisk Product Supply to make data-driven decisions, continuously digitalize, and improve manufacturing processes. The team is very diverse both in terms of capabilities and background, with roles spanning from product owners, scrum masters, architects to hands-on data engineers and developers, and people from 15 different nationalities.

We are currently located in Ballerup and part of DD&IT – a global community of 3000+ colleagues, driving digital, data, and IT. DD&IT partners with the business to support digital transformation and innovation in all parts of the Novo Nordisk value chain – from idea to patient. We accelerate digital value creation through standardised, efficient, and secure technology platforms – the foundation for everything digital in Novo Nordisk.

Be part of the Novo Nordisk family

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 lives for 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.

Bring your questions

For further information, please contact Agile People Leader Milda Bagdonaite. 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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