? Leiden, Netherlands | Full-time | Start ASAP | Long-term contract (potential to become permanent)Company OverviewThis leading healthcare innovator is driving advancements in both Innovative Medicine and MedTech, delivering solutions that transform patient care worldwide. The Leiden site plays a vital role in ensuring operational excellence, developing new production processes, and supporting continuous improvement initiatives.Role OverviewAs a Process Engineer, you'll be at the heart of operations-maintaining, optimizing, and implementing production processes to support high-quality product delivery. You'll work cross-functionally with management and operations teams, ensuring efficient processes, regulatory compliance, and continuous improvement initiatives across manufacturing systems.This role provides the opportunity to influence key technical decisions, implement new technologies, and lead process improvements that directly impact safety, quality, and efficiency.Key ResponsibilitiesSupport introduction, validation, and implementation of new production processes and systemsEnsure smooth operation of existing processes within validated and regulatory limitsCollect, analyze, and report data to drive continuous improvement initiativesLead and participate in troubleshooting process and equipment issuesDevelop strategies with cross-functional teams to minimize downtime and enhance efficiencyContribute to risk assessments, change control, and product impact evaluationsWrite and maintain technical documentation, protocols, and SOPsDrive sustainable process improvements through Gemba walks and CPV activitiesRequirementsBachelor's degree in Engineering, Biotechnology, or related field (or equivalent)6-8 years of relevant experience in process engineering within biotech/pharma/medical devicesStrong technical expertise in manufacturing processes and continuous improvement methodsExcellent problem-solving skills and ability to drive root cause analysisStrong communication skills for cross-functional collaborationFluent in English (both written and spoken)DesirableExperience working in GMP-regulated environmentsProven ability to implement new technologies and optimize production linesFamiliarity with risk management and regulatory expectations in healthcare manufacturing
