Welcome to the team
Our PTS team in Boxmeer supports our Site leadership team in supply, regulatory and compliance activities of existing and new small molecule products, through the demonstration of scientific process understanding to insure reliable, compliant and cost-effective supply, covering technology transfer (site-to-site), process engineering and process validation, complex troubleshooting, change control, process development and improvement, as well as product quality review.
About the role
In this dynamic position you are supporting the commissioning & qualification of our new Small Molecule manufacturing facility, and you will be responsible for the Performance Qualification of the new assets. The new facility is designed for sterile suspended pharmaceutical products.
You will be challenged to (further) develop as a Subject Matter Expert in pharmaceutical production processes, equipment, commissioning & qualification. As Process Engineer you will lead root cause investigations of equipment associated issues, which come up during the C&Q phase and start-up of the new facility.
Primary responsibilities
- Acting as a business user representative ensuring that all relevant requirements are met
- Managing commissioning & qualification activities, including leading Performance Qualifications
- Writing Performance Qualification protocols & reports
- Serve as a troubleshooter for technical issues and challenges for the new facility.
Your profile
- Master or PhD degree in Science (Bio) process technology, Pharmaceutical technology, (Industrial) Chemistry, Food technology, or similar.
- 5-10 years of experience in a technology or in a manufacturing position.
- Experienced as a project manager, connecting multidisciplinary teams, enjoying organizing and supporting individual activities and interactions.
- Experience with GMP, pharmaceutical technology, Lean Six Sigma and statistics are assets.
- Ability to go deep in a project but also handle multiple projects at the same time.
- Excellent communication skills in English and Dutch are required.