Project Lead for Aseptic Processing
4 days ago
As a Project Manager within our Aseptic Processing team, you will play a key part in creating the future standards for an area that covers the last steps of aseptic processing, inspecting our filled-products with multi-format automated equipment, but also changing existing processes that are mainly manual into fully automated, among others, to handle incoming materials for the filling equipment.
Key Responsibilities- Drive defined technical projects within your designated area, while supporting the overall project goals of delivering a world-class solution in a time frame that challenges the traditional approach.
- Prepare documentation and manage test execution and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
- Coordinate with Quality Assurance (QA) and Regulatory Affairs (RA) and design and implement equipment.
- Design and implement training setups for inspection and other relevant compliance activities for the isolator filling line and related process.
- Coordinate and align with local and global PM and WPO peers in an agile PM setup.
- Academic degree within natural sciences, engineering, or similar.
- From 3 to 5 years of relevant experience in project management.
- Project management experience of technical or complex projects.
- Experience with aseptic process production design and GMP experience – ideally from the pharma industry.
- Experience with driving design processes, documentation for qualification and implementation of new equipment.
- A quality mindset and a drive to create the 'right' solutions while challenging the status quo supported with data.
- An excellent command of verbal and written English.
We are Fill & Finish Expansions, a newly established and growing area within Product Supply, Quality & IT, with a global approach to design, plan, and build major fill & finish expansion projects across PSQIT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology.
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