Project Engineer - Syringe Filling

Prochem Engineering; Leinster; On-site; EUR 75,000 - 110,000; Full time

Job summary

Prochem Engineering in South Dublin seeks an experienced Project Engineer – Systems Owner Engineer for syringe filling equipment as part of a major site expansion. You will lead from design through installation qualification and into commercial operation, ensuring readiness and adherence to GMP standards.

The role requires a strong background in aseptic filling systems, regulatory knowledge, and the ability to coordinate across Manufacturing, Quality, Automation, and Validation teams to deliver

Qualifications

• Bachelor’s degree in mechanical, electrical, chemical, or related engineering.
• 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.
• Experience with single-use technologies in fill-finish environments desirable.
• Demonstrated ability to lead complex equipment projects from design through operational readiness.
• Strong troubleshooting and root cause analysis capability.

Responsibilities

• Act as System Owner for syringe filling equipment from design through 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, 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.

Skills

GMP knowledge

Regulatory knowledge

Aseptic processing

Root cause analysis

Project leadership

Troubleshooting

Education

Bachelor’s degree in mechanical, electrical, chemical, or related engineering

Job description

• 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.