Validation Lead

Do you have a strong drive and excellent quality/validation skills? Are you ready to play a key role in defining and leading the validation strategy, to drive efficiency across Novo Nordisk production? Then apply now and become our new Validation Lead!
Let's talk about the role
As the MES (Manufacturing Execution System) CoE Validation Lead, you will play a crucial role in ensuring the validated state of the system (PAS-X), maintaining compliance with regulatory requirements, and driving continuous improvement through innovative validation and qualification strategies.
Your key responsibilities will be to:

• Define and execute validation and qualification strategies for MES CoE alongside another lead.

• Foster strong relationships with colleagues and stakeholders through effective communication, including workshops and risk assessments.

• Manage end-to-end validation activities, from planning to execution, including design review and test strategy.

• Conduct various assessments, such as supplier assessment, IT risk assessment, and functional integrity assessments.

• Maintain system validation through periodic reviews, documentation, and addressing deviations, ensuring compliance with regulatory requirements.

Which competencies to bring?
To be our new Validation Lead, we are looking for a candidate who can tick off the following requirements:

• Academic degree 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.

• As our corporate language is English, written and spoken English is required and Danish will be a plus.

• Experience with PAS-X or other automation systems will be a clear advantage.

On a personal level, you will be a great fit for this role if you are problem-solver with a knack for driving continuous improvement. You have strong analytical skills, meticulous attention to detail, and a structured approach to validation activities. Finally, effective communication is key in our team, whether you're engaging with technical experts or conveying complex ideas in writing.
The team waiting for you
The department, MES Programme CoE is anchored in DD&IT (Data, Data & IT) Product Supply and is focused on implementing the Manufacturing Execution System used across Novo Nordisk. We set the strategic direction and ensure that processes across production lines are automated and optimised. The team is primarily located in Bagsværd (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
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 our Hiring Manager Linda Kirsten Høyer at [email protected]
Deadline
20 September 2024
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.
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.