Lead Syringe Filling Systems Engineer – GMP/Validation

Prochem Engineering; Leinster; On-site; EUR 85,000 - 120,000; Full time

Job summary

Prochem Engineering seeks an experienced Project Engineer – Systems Owner Engineer – Syringe Filling for a bio-pharmaceutical facility in South Dublin. You will lead the implementation and readiness of syringe filling equipment and single-use systems as part of a major site expansion.

You will own the system from design through PQ and validation, drive manufacturing readiness, and ensure GMP compliance, collaborating across Manufacturing, Quality, Validation, and Global Engineering to deliver

Qualifications

• Bachelor’s degree in an engineering discipline.
• 5+ years’ experience in bio-pharmaceutical manufacturing engineering.
• Proven experience in aseptic syringe filling systems.
• Strong knowledge of GMP, regulatory expectations and Annex 1.
• 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 skills.

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

System Owner

Syringe Filling

FAT/SAT

IQ/OQ/PQ

Validation

GMP Compliance

Annex 1

Aseptic Processing

Single-use Tech

Troubleshooting

Root Cause Analysis

Project Leadership

Cross-functional

Education

Bachelor’s degree in mechanical/electrical/chemical engineering

Job description

Prochem Engineering seeks an experienced Project Engineer – Systems Owner Engineer – Syringe Filling for a bio-pharmaceutical facility in South Dublin. You will lead the implementation and readiness of syringe filling equipment and single-use systems as part of a major site expansion.

You will own the system from design through PQ and validation, drive manufacturing readiness, and ensure GMP compliance, collaborating across Manufacturing, Quality, Validation, and Global Engineering to deliver