Syringe Fill Systems Owner Engineer – GMP-Ready Scale-Up

Prochem Engineering; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

Prochem Engineering seeks an experienced Project Engineer – Systems Owner Engineer for a syringe filling expansion at a South Dublin bio-pharmaceutical facility. You will own the syringe filling system from design through to PQ and commissioning, ensuring readiness for GMP production.

You will lead validation activities (IQ/OQ/PQ), drive equipment lifecycle plans, and collaborate with Manufacturing, Quality, Validation and Global Engineering to deliver a compliant, high-speed fill-finish

Qualifications

• GMP knowledge and regulatory expectations
• Aseptic processing principles, Annex 1 familiarity
• Equipment validation lifecycle (IQ/OQ/PQ)
• Experience with single-use technologies in fill-finish environments desirable
• Proven ability to lead complex equipment projects from design to operation
• Strong troubleshooting and root cause analysis capability

Responsibilities

• Act as System Owner for syringe filling equipment from design through to PQ and commercial operation.
• Lead equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities.
• Drive manufacturing readiness, start-up, and handover to operations.
• Ensure GMP, regulatory, and company standards compliance.
• Develop and implement maintenance strategies, critical spare parts, preventive maintenance, and lifecycle asset management.
• Provide technical leadership during deviation investigations, troubleshooting, and performance optimization.
• Partner cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering.
• Support new product introduction and technology transfer activities.

Skills

GMP compliance

Aseptic processing

Equipment validation lifecycle

Single-use technologies

Project leadership

Root cause analysis

Cross-functional collaboration

System Owner

Deviation investigations

Education

Bachelor’s degree in Mechanical Engineering

Job description

Prochem Engineering seeks an experienced Project Engineer – Systems Owner Engineer for a syringe filling expansion at a South Dublin bio-pharmaceutical facility. You will own the syringe filling system from design through to PQ and commissioning, ensuring readiness for GMP production.

You will lead validation activities (IQ/OQ/PQ), drive equipment lifecycle plans, and collaborate with Manufacturing, Quality, Validation and Global Engineering to deliver a compliant, high-speed fill-finish