Description du poste
Project Engineer - Syringe Filling PROCHEM Engineering Dublin, Ireland Role Summary: A fantastic opportunity has arisen for an experienced Project Engineer Systems Owner Engineer Syringe Filling at our client s bio-pharmaceutical facility in South Dublin. The System Owner Engineer (SO) will lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion in South Dublin. This is a critical role supporting a high-speed, GMP-regulated fill-finish manufacturing environment. Core Duties and Responsibilities: Act as System Owner for syringe filling equipment from design through to PQ and commercial operation. System owner during equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities. Drive manufacturing readiness, start-up, and handover to operations. Ensure compliance with GMP, regulatory, and company global standards. Develop and implement: Maintenance strategies Critical spare parts strategy Preventive maintenance programs Lifecycle asset management plans Provide technical leadership during deviation investigations, troubleshooting, and performance optimisation. Partner cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering. Support new product introduction and technology transfer activities. Minimum Qualifications and Experience: Bachelor s degree in mechanical, Electrical, Chemical, or related Engineering discipline. 5+ years experience in bio-pharmaceutical manufacturing engineering. Proven experience in aseptic syringe filling systems (high-speed lines preferred). Strong knowledge of: GMP and regulatory expectations Annex 1 Aseptic processing principles Equipment validation lifecycle Experience with single-use technologies in fill-finish environments is desirable. Demonstrated ability to lead complex equipment projects from design through operational readiness. Strong troubleshooting and root cause analysis capability. Apply Now