Filling Professional

at  Novo Nordisk

Filling Professional
Category: Manufacturing
Location:Lyngby, Capital Region of Denmark, DK
Do you want to be a part of the development of the future Aseptic Processing facilities 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, Performance verification (PfV) and Process validation (PV) 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).
• Support sites during critical stages of PfV and PV of the filling line.
• Be part of vendor oversights during equipment construction and test phase.
• Develop future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
• Project coordination of tasks within the Filling work package.
• Design and implementation of training setup for operations as well as authority inspection and other relevant compliance activities.

We are looking for more than one candidate for this opportunity.

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, as technician, supporter, mechanical engineer, chemical engineering, food science or similar education.
• Preferably 5 years or more experience from the pharma industry or other regulated industry where GMP or similar requirements exist.
• Experience with designing, qualification, commissioning or filling processes would be a key to succeed in this role.
• Experience from large scale international project work.
• Experience with other areas such as single use systems, filter testing, innovation tracks, robotics and quality would be a plus but not a requirement.
• Experience with Filling and isolators and working with multinational stakeholder landscapes are considered as an advantage.

As an ideal candidate for this role, you can communicate fluently in English, both in written and spoken form. 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. As a person 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. Later stages will involve travels to support our global sites until the filling line goes into operations.

The key tasks will be:

• Preparing documentation and execute test and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
• Support sites during critical stages of PfV and PV of the filling line.
• Be part of vendor oversights during equipment construction and test phase.
• Develop future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
• Project coordination of tasks within the Filling work package.
• Design and implementation of training setup for operations as well as authority inspection and other relevant compliance activities

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, as technician, supporter, mechanical engineer, chemical engineering, food science or similar education.
• Preferably 5 years or more experience from the pharma industry or other regulated industry where GMP or similar requirements exist.
• Experience with designing, qualification, commissioning or filling processes would be a key to succeed in this role.
• Experience from large scale international project work.
• Experience with other areas such as single use systems, filter testing, innovation tracks, robotics and quality would be a plus but not a requirement.
• Experience with Filling and isolators and working with multinational stakeholder landscapes are considered as an advantage