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Lead Process Engineer

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SIRE Life Sciences Logo Lead Process Engineer, Leiden, Zuid-Holland Location: Leiden, Zuid-Holland | Sector: Pharmaceuticals | Start Date: 10/9/2026 | Job ref: 59074 Company 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. Job Description 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 C...

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