Process Specialist

Location -, Denmark
Discipline: Biotechnology
Contact name: Caitlin Girdwood

Contact email: c.girdwood@panda-int.com
Job ref: 10676
Published: about 1 month ago
Are you newly educated, or do you have some years of experience with production processes in an aseptic production environment? Are you proactive independently driving initiatives and ready to take your talent to the next level? Would you like to become part of a newly established team that are playing a significant role in introducing new products into our fill & finish production? Then you might be the Process Specialist we are looking for!

Join our transformative journey
Bavarian Nordic has with our recent acquisition of two established commercial vaccines and the FDA-approval of our smallpox vaccine embarked upon a truly transformative journey to become one of the largest pure play vaccine companies, improving and saving lives by excelling in R&D innovation, manufacturing and commercialization.

With the completion of our fill and finish facility at our manufacturing site in Kvistgaard we will be able to carry out all parts of the chain in vaccine manufacturing. Our new fill & finish facility is currently being qualified and we plan to be ready for commercial production in 2022. As part of this progressive journey we are now looking for a Process Specialist to support the processes of introducing new product into our fill & finish facility.

It’s not a job, it’s a career
You will become a part of a newly established area which is playing a significant role in introducing new products into the fill & finish facility as we are starting to move newly acquired products into Bavarian Nordic in order to manufacture them at the new facility.

The large-scale production processes in our fill & finish facility are formulation, wash & sterilization, filling line, freeze dryer, inspection, label and packaging line and other surrounding processes. The level and areas of responsibility will depend upon your level of experience, but can include formulation, preparation/ wash & sterilisation, filling, freeze drying and visual inspection.

In all your endeavours, you will collaborate with colleagues across the company. You validate research together with Manufacturing Development, and when you implement new equipment or optimise current systems or processes, Technical Service assists you. Also, you will interact with external stakeholders such as regulatory authorities during inspections and QA is a natural partner for you.

You will be reporting to the Manager, New product introduction, FnF.

Supporting changes in production processes
As Process Specialist you will be supporting the coordination and decision making around the aseptic processes for the new products. This includes ensuring progress - and along the way ensure that the entire value chain is involved in changes in aseptic processes and that input from the various stakeholders arrives on time. The task is including but not limited to;
 
  • Making change request reports
  • Making deviation reports
  • Validation and process qualification
  • Writing SOP’s
     
Together with the New Product Introduction team you will secure effective coordination to prepare a smooth and predictable introduction and handover of product to the new cGMP facility for timely and stable operation. After PPQ of the various new products you will continue working to improve the processes.

Proactive and motivated by challenges
 
  • You have a master’s degree specializing in engineering, chemistry, biology, biotech, pharmaceutics or others relevant field
  • You are newly educated or have some years of experience within pharmaceutical production
  • You speak and write Danish and English fluently
     
As a person you are excellent at coordinating activities and being persistent in getting input from a broad variety of stakeholders on time. You are a positive and pro-active team player and motivated by the dynamics which follows establishing our new facility. You take ownership and responsibility for your areas of responsibility. You work systematic and detail oriented to secure quality. It is also natural for you to support colleagues across processes in a “we are one team” mentality.

We offer
A chance to become a part of the implementation of the new large-scale aseptic production line and to work in an international company with unique technology and a dedicated work force. We offer you a chance to work in a dynamic work environment and an opportunity to develop both your personal and academic competencies.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

We are interviewing on an ongoing basis.