Lead Process Engineer

Our client is a leading organization in the life sciences sector, operating in a highly regulated manufacturing environment. They are committed to quality, safety, and continuous improvement, and work to strict industry standards such as GMP. The site offers a professional setting where cross-functional collaboration and process optimization are key to ongoing success. We are looking for a Lead Process Engineer to support and improve production processes in a GMP-regulated environment.

This role focuses on ensuring smooth day-to-day process performance, identifying improvement opportunities, and driving sustainable changes that enhance quality, efficiency, and compliance. The Senior Manufacturing Process Engineer will work closely with operations, engineering, and quality stakeholders and will take ownership of process-related investigations, assessments, and documentation.

Responsibilities: Support the introduction of new production processes and/or systems and help ensure successful implementation on the shop floor; Maintain stable operation of existing production processes by addressing issues impacting quality, output, yield, and downtime; Continuously evaluate and improve processes to increase efficiency, reduce losses, and support overall production goals; Ensure processes operate within validated ranges and regulatory requirements, escalating risks and issues when needed; Create, review, and maintain process documentation such as SOPs, work instructions, and master batch records; Perform and support quality risk assessments and periodic document reviews; Act as a subject matter expert for process-related impact assessments; Support investigations of deviations/non-conformances and contribute to change controls and CAPA ownership; Support performance qualification (PQ) activities and assist with validation of supporting processes when required; Conduct Gemba walks, observe operational execution, and lead sustainable improvements in safety, quality, reliability, cost, and scheduling; Contribute to inspection/audit readiness by providing process input and acting as a process representative when needed; Support continuous process verification and annual product review activities by gathering data and performing follow-up analysis.

Requirements: Relevant HBO-level degree; At least 3 years of relevant experience in a production/process engineering environment; Strong understanding of GMP and working in a regulated manufacturing setting; Comfortable with documentation standards (SOPs, work instructions, batch records); Experience with deviations, change controls, CAPA, and risk assessments is a strong advantage; Good English communication skills (minimum B2 level); Proactive, organized, and able to stay calm under pressure while managing changing priorities; Strong analytical skills and ability to work both independently and collaboratively.

Other Information: The role is based hybrid in Leiden, within a regulated manufacturing environment. If you are interested and want to apply, please submit your application via the apply button below and contact me.