OT Business Analyst - Engineering Responsible

Are you passionate about engineering and ensuring compliance with quality standards? Are you looking for a role that combines your analytical skills with your passion for engineering?

If so, we have an exciting opportunity for you to join Novo Nordisk as an OT Business Analyst - Engineering Responsible in Serialisation Production.

Apply today for a life-changing career!

Let’s talk about the role
As an OT Business Analyst - Engineering Responsible, you will facilitate verification and validation activities including test execution, documentation review and approval.

This role can give you the chance to set validation direction for implementation projects, if you aspire to that level. However, we are looking for a strong validation profile to join our team, so if you don't see yourself in this role just yet, don't worry - this role could still be a great fit for you with space for growth and development.

In this role you will also have the opportunity to:

•  Participate in validation projects as validation responsible, performing validation of infrastructure within our facilities
• Conduct technical and/or validation troubleshooting on implemented Serialization Site Servers and Line controllers
• Work collaboratively with Quality Assurance, Line of Business, and vendors to plan, coordinate, and execute validation activities
• Facilitate verification and validation activities including test execution, documentation review, and approval

You will collaborate with internal and external stakeholders to ensure the successful execution of projects and the maintenance of technology infrastructure across different regions.

The position involves working with dynamic projects with potential travel to vendor and production sites in various countries, including Germany, France, Brazil, the US, China, and Denmark.

Candidate Profile
To be the ideal candidate for this position, we imagine you meet most of the following requirements:

• Master’s or bachelor’s degree in engineering or similar field, combined with experience in manufacturing, preferably in serialisation
• Knowledge of Good Engineering Practice (GEP), including engineering and technical/industry standards, e.g., International Society for Pharmaceutical Engineering (ISPE), American Society for Testing and Materials (ASTM), Parenteral Drug Association (PDA), International Organization for Standardization (ISO)
• Expertise in technical disciplines such as automation, testing and validation of engineering processes, including familiarity with testing software tool e.g. eTIMS
• Understanding of authority requirements e.g., Good Manufacturing Practice (GMP)
• Deviation handling experience
• Audit experience, also including participating and executing vendor audits together with audit facilitators and colleagues is an advantage
• Experience in Quality Management Systems (QMS) and preferably Novo Nordisk validation approaches e.g. OurValidation

Additionally, experience from GxP background would be advantageous.

As a person, you are flexible, curious and wiling to experiment. You also have a high sense of responsibility and thrive working collaboratively in a team environment within agile framework.

About the department

Digital, Data & IT, Product Supply, Production is anchored within the Digital, Data & IT organisation and has approx. 4.000 employees based in Denmark, India, US, China, France, and Brazil. The strategic objective of the unit is to be the IT partner for the business, ensuring that we provide the IT solutions and support the Novo Nordisk production solution needs worldwide. 

In Digital Data & IT, Product Supply, Production, OT Enabler Center of Excellence we are on the brink of a transformative journey towards being a Center of Excellence (CoE).

Our team is characterised by a trust-based environment, high skilled peers with a quality mindset.

The team is located in our newly renovated and established DD&IT campus in Ballerup (Greater Copenhagen area), Denmark. The focus in the team is to be trusted partner to Line of Business and expansion programs.. You will work with experienced Product Architect, Product Owner, Product Managers and OT analysts to achieve the Serialisation Production strategy.

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 57,000 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. That said, opportunities are many in Novo Nordisk.

Every day, thousands of our digital experts work in all areas of technology. We navigate the tech spectrum from front-end to back-end, from artificial intelligence to machine learning, and from cloud systems to quantum computing. All to make a tangible impact on lives across the globe. How? Go explore at  TechLife at Novo Nordisk.

Contact

For further information, please contact People Leader, Lena Jensen +45 34485650.

Deadline:

12 February 2025

Feeling overwhelmed by job requirements and doubting if you're 100% qualified? Don't let it stop you! We encourage you to apply anyway, as your profile could surprise us and fit our needs better than you think. So, take the leap and submit your application.

To ensure a fair and equal recruitment process, please refrain from adding a picture in 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.