Werkzaamheden
The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion. Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify, analyze and prioritize technical or business related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes, systems and behaviors. Contribute to a data driven decision making process, Ensure effective application of LeanSixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners. Minimal work direction needed, highly skilled and knowledgeable to the position.
About the role
In this dynamic position you are responsible for challenging technology projects to support current manufacturing of Boxmeer Small molecule products as well as supporting and leading global (strategic) projects and activities. The majority of these projects will be concentrated around sterile suspended pharmaceuticals.
You will be challenged to (further) develop as a Subject Matter Expert in the area of pharmaceutical production processes. In this position you will gain knowledge of (sterile) manufacturing and the associated requirements including raw material, equipment /and process changes and analytics.As Process Engineer you will lead root cause investigations of major manufacturing or quality issues, projects for continuous improvement and technology transfer. You will have to connect to suppliers, contract manufacturers and external laboratories, including occasional external visits across Europe.
Primary responsibilities
- Managing end-to-end technical projects at the Boxmeer site, including API-, packaging and process-related changes, and leading cross-functional teams for the submission, approval and implementation of these efforts.
- Collaborate with Manufacturing (sites), Quality, Engineering, Supply Chain, Regulatory Affairs, Pharma R&D, Procurement, and Contract Manufacturing Organizations.
- Serve as a troubleshooter for technical issues and challenges in the manufacturing environment.
- Lead the introduction of new technology platforms.
- Provide in-line product support and implement productivity initiatives through scientific rigor and appropriate technical expertise.
- Support regulatory inspections for PTS-owned GMP systems.
- Engage in knowledge management, communities of practice, virtual technical networks, and best practices sharing.