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.