Isolator Filling Specialist

6 months ago

Lyngby, Denmark Novo Nordisk AS Full time

Do you want to be a part of the development of the future Aseptic Processing facilities in a large global pharmaceutical company and are you motivated by implementing and validating these technologies? Are you considered an expert within the aseptic production processes including isolator filling technology? Does global collaboration and team work across cultures come naturally to you? 

If yes, then you might be the Isolator Filling Specialist we are looking. Apply now 

The Position 
As the Isolator Filling Specialist you will be a key player in defining and specifying technical requirements under the filling isolator process, along with testing and validation aspects. You will be engaged together with our Central Manufacturing Development team, Senior Project Managers, other specialists, and Subject Matter Experts in the Fill Finish Expansions program locally and across global sites. 

You will play a large role in ensuring that the Filling solution is well documented and implemented to deliver the business impact. You will be expected to use your previous Isolator Filling line experience working within the Filling Work package on various technical tracks within the project framework. 

The filling work package is responsible for delivering 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 subsequent SAT-IQ-OQ phases in our production floors globally. 

The key tasks will include: 

Using your specialist knowledge in developing technical solutions in various sub-projects running in the filling work package. 

Development of future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements. 

Key player in vendor oversight during the equipment design, build and test phases thus leading up to participation in Factory Acceptance Tests (FAT). 

Providing guidance in the creation of test protocols and reviewing them for the respective FAT, SAT, IQ/OQ and further CQV phases. 

Design and implement training setup for operations with focus on a high reliability manufacturing. 

Setting the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (including calibration and maintenance strategy approach). 

Qualifications 
To be successful in this role you need to have: 

A background within the natural science or engineering areas

+10 years of work experience within aseptic filling operations, that caters around Isolator Filling technology. 

Significant experience from the pharma industry or other regulated industry where GMP (Good Manufacturing Practices) and similar requirements exist. 

Significant experience from project work including introduction of new technologies or processes. 

A quality mindset and a drive to create the “right” solutions while challenging the status quo. 

An excellent command of verbal and written English. 

As a person you are comfortable with taking initiative and have a strong personal drive and dedication. 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.

About the Department 
Our department Technology Standards is situated in the newly created SVP area of Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees. 

Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and built all new aseptic filling capacity across Novo Nordisk to serve needs of millions of patients. We do it by rethinking our aseptic production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. Fill & Finish Expansions has a clear global approach, where you will be working with multiple sites and cultures across the world.

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