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- Assisting in troubleshooting and providing general support to aseptic production at pharmaceutical sites.
- Maintaining global corporate documents and procedures for pharmaceutical production.
- Supporting in the qualification of technologies and driving improvements across the organization.
- Participating in audits and inspections.
- A master's degree in Biology, Pharmacy, Engineering, Microbiology, or a related field.
- Over 5 years of expertise in environmental monitoring of cleanrooms in aseptic production.
- Experience in cleanroom and equipment validation, re-validation.
- Hands-on experience with Aseptic Process Simulation (APS – media fill).
- Strong analytical and statistical skills.
- Thorough understanding of regulatory requirements for Environmental Monitoring in cleanrooms.
- Excellent quality sense and familiarity with Quality Management System documentation.
Environmental Monitoring Professional - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you knowledgeable in Environmental Monitoring (EM) of pharmaceutical Aseptic Production? Are you ready to share your expertise with colleagues worldwide and contribute to shaping the future of aseptic manufacturing at Novo Nordisk?
If this sounds like you, consider joining us as the new Environmental Monitoring Professional in Søborg. Keep reading for more details. Take the first step towards an impactful career.
The Role
Environmental Monitoring plays a crucial role in maintaining aseptic conditions in our production cleanrooms. You will be instrumental in ensuring that Novo Nordisk Aseptic Filling Facilities at our global production sites operate efficiently and in compliance. Your responsibilities will include supporting ongoing production, new projects, environmental monitoring, qualification, aseptic operations, and cleaning/gowning.
Key responsibilities:
You will collaborate with colleagues from diverse backgrounds, work out of Søborg, Denmark, and may travel up to 20 days a year to support our global facilities. Additionally, there will be ample opportunities for growth, development, and taking on new challenges.
Qualifications
Your background should include:
As an individual, you are service-oriented, goal-driven, and a collaborative team player. You excel in dynamic environments, can effectively prioritize tasks, and take pride in delivering outstanding support to colleagues. Proficiency in both written and spoken English is a must.
About the Department
The Injectable Finished Products (IFP) department produces high-quality products globally to combat diabetes and obesity. Site Support & Improvements (SSI) is a vital part of IFP Manufacturing Support, dedicated to enhancing our global IFP aseptic production sites through innovation, technology advancements, and production optimization. We emphasize making a positive impact by implementing data-driven solutions in alignment with GMP regulations.