Wash & Sterilisation Professional

4 weeks ago


Søborg, Denmark Novo Nordisk AS Full time

Are you well versed in both Wash & Sterilisation (W&S) in Aseptic Production? Do you have in dept knowledge of Aseptic Production in cGMP environment W&S laboratory studies and validation? Can you support colleagues both practically or scientifically and would you be excited to support and be part of shaping the future of aseptic manufacturing at Novo Nordisk? 
Then this might be the position for you. Apply today and join us for a life-changing career.
 

The position
Wash & Sterilization is one of the prerequisites for compliant pharma production. You will play an important role in providing scientific data and supporting cleanability and degradation studies with protocols, conduct and reports. You will also support daily operation, projects, audits, and inspections.
As a department, we support running production and new projects. We are responsible for the interaction between production processes and interpretation of external (GMP) requirements and ensures that processes are scientifically built and anchored in our documentation.
We interpret external (GMP) requirements and ensure global harmonization. As part of this, we support the sites with creation of documentation such as Global SOPs, Change Requests and Deviations.
 

A workday may include: 

Participation in troubleshooting and support in general. Maintenance of global corporate documents and procedures.  Support to laboratory studies such as cleanability and recovery studies.

You will be cooperating with colleagues from different cultures, with different areas of expertise and at different organizational levels. You will be working out of Søborg, Denmark, but travel may be required. 
There will be plenty of opportunities to take on new responsibilities and grow in this position.
 

Qualifications
To succeed in this role:

You have relevant academic background (MSc Eng., MSc.Pharm etc.) cGMP/Validation experience. In depth knowledge of Aseptic Production in cGMP environment. In depth knowledge of wash and sterilization in cGMP environment. Have supported W&S laboratory studies such as cleanability and recovery studies to support our cleaning documentation. You have strong analytical and statistical skills. You are well versed in regulatory requirements for W&S.  You have a high sense of quality and know how to handle Quality Management System documentation. You are service minded, goal oriented and a strong team player. You are used to and thrive working in a dynamic environment and can prioritize between many important tasks.  You set a pride in providing excellent support to colleagues.  You are fluent in written and spoken English.  Good communication skills at all organizational levels.

About the department
The Injectable Finished Products (IFP) area produces high-quality products to fight diabetes and obesity worldwide. Site Support & Improvements (SSI) is a dynamic department in IFP Manufacturing Support, supporting our global IFP aseptic production sites and setting the direction for new technologies, innovation, and production optimization globally. We have a strong focus on making a difference in close collaboration with the IFP aseptic production sites, by implementing novel solutions based on data-driven decisions and in accordance with GMP regulations.
 



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