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Aseptic Process Development Specialist
2 months ago
We are seeking a skilled Aseptic Process Development Specialist to join our team in Fill & Finish Expansions at Novo Nordisk A/S. This is an exciting opportunity to work on the development of future aseptic processing facilities and implement innovative technologies.
About the JobThe successful candidate will be responsible for defining technical requirements, testing, and validation aspects related to the filling isolator process. This role involves collaboration with cross-functional teams, including Central Manufacturing Development, Senior Project Managers, and Subject Matter Experts.
Main Responsibilities- Developing technical solutions for various sub-projects within the filling work package
- Designing future process flows that adhere to aseptic standards and authority requirements
- Participating in vendor oversight during equipment design, build, and test phases, including Factory Acceptance Tests (FAT)
- Providing guidance on test protocol creation and reviewing them for FAT, SAT, IQ/OQ, and CQV phases
- Designing and implementing training setups for operations focusing on high-reliability manufacturing
- Ensuring a risk-based approach to validation and maintaining the validated state of equipment, including calibration and maintenance strategy
- A background in natural science or engineering
- +10 years of experience in aseptic filling operations, specifically with Isolator Filling technology
- Significant experience from the pharma industry or regulated industries with GMP (Good Manufacturing Practices) and similar requirements
- Experience in project work, including introducing new technologies or processes
- A quality mindset and drive to create the right solutions while challenging the status quo
- Excellent command of verbal and written English
This role offers a competitive salary range of €80,000 - €110,000 per annum, depending on experience. You will also have opportunities for professional growth and development within a global organization.
