Key Skills

Job Description

Process Engineer II We are looking for a Process Engineer II to support the introduction of new products and processes within a highly regulated manufacturing environment. In this role, you will drive technology transfers, process improvements, investigations, and change implementation while working closely with Operations, Quality, Engineering and Supply Chain teams. You will use Lean Six Sigma and Change Management methodologies to identify improvement opportunities, resolve technical challenges, and support data-driven decision making. Key responsibilities: ▪ Support product and process transfers into manufacturing ▪ Lead and participate in cross-functional investigations, root cause analyses and CAPA activities ▪ Drive continuous improvement initiatives using Lean Six Sigma tools ▪ Facilitate process optimization and change implementation projects ▪ Collaborate with Operations, Quality, Engineering and Supply Chain stakeholders ▪ Contribute to a culture of operational excellence and continuous improvement Ideal background: ▪ Experience in pharmaceutical, biotech, medical device or other regulated manufacturing environments ▪ Process engineering, manufacturing support or technology transfer experience ▪ Knowledge of GMP environments ▪ Lean Six Sigma and continuous improvement mindset ▪ Strong stakeholder management and problem-solving skills ▪ Fluency in both English and Dutch

Core Responsibilities

Support the transfer of products and processes into manufacturing, and lead or participate in investigations, root cause analyses, and CAPA activities. Drive process optimization, change implementation, and continuous improvement initiatives while collaborating with Operations, Quality, Engineering, and Supply Chain teams.

Requirements

Experience in process engineering, manufacturing support, or technology transfer within pharmaceutical, biotech, medical device, or another regulated manufacturing environment is sought, along with knowledge of GMP. The role also calls for a Lean Six Sigma and continuous improvement mindset, strong stakeholder management and problem-solving skills, and fluency in English and Dutch.