Process Engineer

Our client is a global healthcare organization with a strong focus on quality, innovation, and reliable manufacturing. You will work in a GMP production environment where process performance, product quality, and continuous improvement are key priorities. As a Process Engineer, you will maintain, improve, and support manufacturing processes to ensure safe, compliant, and efficient production. You will work closely with Operations, Quality, Engineering, and other stakeholders to resolve process issues and implement sustainable improvements.

Key Responsibilities: Support the introduction of new production processes and systems. Maintain and improve existing GMP production processes. Monitor process performance, yield, quality, and downtime. Identify process risks, root causes, and improvement opportunities. Lead or support CAPA, non-conformance, and change control activities. Act as Subject Matter Expert for process-related topics. Ensure SOPs, Work Instructions, and Master Batch Records remain accurate.

Support process and equipment Performance Qualification and validation activities. Conduct Gemba walks and implement sustainable process improvements. Support audits, inspections, CPV, and Annual Product Review activities.

Requirements: Relevant HBO degree with at least 3 years of relevant experience. Experience in process engineering within a GMP or regulated production environment. Strong knowledge of production processes, process improvement, and root cause analysis. Experience with CAPA, deviations/non-conformances, change control, and risk assessments. Familiarity with process validation and Performance Qualification. Strong analytical and problem-solving skills.

Proactive, organized, accurate, and comfortable working independently. Able to manage changing priorities and work effectively under pressure. Strong stakeholder management and communication skills. English required; Dutch is a plus.