The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.
Primary responsibilities for the Commissioning and Qualifications Engineer include:
- Commission and Qualify (C&Q) various process and laboratory equipment.
- Design and execute process validation studies for the large Scale API processes.
- Review and assess change control for API processes to determine impact on validated state.
- Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
- Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc. Position will receive direction and support.
- Requires degree in Mechanical or Chemical Engineering.
- Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.