- Participation in troubleshooting and general support to aseptic production at pharmaceutical sites.
- Maintenance of global corporate documents and procedures for pharmaceutical production.
- Support in qualification of technologies and improvements across the organization.
- Provide support in audits and inspections.
- A master's degree within Biology, Pharmacy, Engineering, Microbiology or equivalent
- 5+ years expertise within one or more areas of environmental monitoring of cleanrooms in aseptic production.
- Experience with cleanroom and equipment validation, re-validation.
- Experience with Aseptic Process Simulation (APS – media fill).
- Strong analytical and statistical skills.
- Good understanding in regulatory requirements for Environmental Monitoring in cleanrooms.
- High sense of quality and experience in handling of Quality Management System documentation.
Environmental Monitoring Professional - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you well versed in Environmental Monitoring (EM) of pharmaceutical Aseptic Production? Are you service minded and ready to make your knowledge available to operational colleagues world-wide? Would you be excited to support and be part of shaping the future of aseptic manufacturing at Novo Nordisk?
If so, you could be our new Environmental Monitoring Professional based in Søborg. Read on to find out more and apply today. Join us for a life changing career.
The position
Environmental Monitoring is an important part of ensuring aseptic conditions in our production cleanrooms. You will play a critical role in ensuring that Novo Nordisk Aseptic Filling Facilities, at our global production sites world-wide operates compliant and efficiently. As a department, we both support running production and new projects. We are responsible for the interaction between production processes and interpretation of external (GMP) requirements.
Additional responsibilities involve supporting our sites in environmental cleanroom monitoring, qualification, aseptic operations, and cleaning/gowning.
Key responsibilities include:
You will be cooperating with colleagues from different cultures, different areas of expertise and at different organizational levels. You will be working out of Søborg, Denmark, and travel up to 20 days over the course of the year may be required in support of our global facilities. Furthermore, there will be plenty of opportunities to take on new responsibilities, growth, and development.
Qualifications
Your experience include:
As a person, you are service minded, goal oriented and a strong team player. You are accustomed to and thrive working in a dynamic environment. You can prioritize between many important tasks. You set pride in providing excellent support to colleagues and are fluent in written and spoken English.
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.