Novo Nordisk
Filling Professional within Aseptic Production
Do you want to be a part of the development of the future Aseptic Processing facilities future in a large global pharmaceutical company? Are you motivated by developing and implementing new technology and challenging status quo? Does close international collaboration and networking across boundaries come natural to you, and are you familiar with the different aspects of aseptic production processes?
If yes, then you might be the Filling Professional within Aseptic Production we are looking for to develop and support implementation of the technology solutions needed to drive the establishment of our new aseptic production lines across the world.
The Position
As a Filling Professional within Aseptic Production you will be a key player in specifying and defining the Filling solution, together with line of business, the senior project manager and subject matter expert responsible for the Filling process in the Fill Finish Expansions programme.
You will play a large role in ensuring that the Filling solution is well documented and implemented to deliver the business impact.
The filling work package is responsible for delivering a multiformat filling line sitting inside an isolator, solutions designed for minimal human interventions and of the highest compliance. The work package also has the mandate to check the progress of machine construction via oversight activities at supplier site thus leading up to managing successful FAT and partially in the subsequent SAT-IQ-OQ phases in our production floors globally.
The key tasks will be:
Preparing documentation and execute test and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
Project coordination of tasks within the Filling work package.
Development of future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
Be part of the vendor oversight during the equipment build and test phase.
Involved in cross functional activities as single use systems, filter testing etc.
Design and implementation of training setup for operations as well as authority inspection and other relevant compliance activities.
Qualifications
In the role as a Filling Professional within Aseptic Production, we expect you to have:
Bachelor’s degree or higher within the natural science or engineering areas, which could be as technician, supporter, mechanical engineer, chemical engineering, pharmaceutical, food science or similar education.
More than 2 years of experience from the pharma industry or other regulated industry where GMP or similar requirements exist.
Experience with Filling and isolators are a great advantage.
An excellent command of verbal and written English.
Experience from project work and project management is desirable.
As a person you are comfortable with taking initiative, have a strong personal drive and dedication to create the “right” solutions. You bring a good sense of humour to work even when pressure is on, and you thrive in a changing and dynamic environment. You demonstrate attention to detail, and you are structured in your problem-solving approach. Furthermore, you embrace professional and personal diversity.
It is to be noted that the role requires you to travel when needed to vendor sites that is mostly situated within Europe for project discussions or overseeing tests and other activities happening on the machine.
About the department
You will be joining Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approximately 28,500 employees. Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across PSQIT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the future, designing facilities we will still be proud of many decades from now. Fill & Finish Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
To learn more about Fill & Finish Expansions in Novo Nordisk visit our career site here: Let's build the future for patients: Exciting Careers in Growing Expansion Project (novonordisk) .
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