Lead Syringe Filling Systems Owner Engineer

Prochem Engineering; Leinster; On-site; EUR 85,000 - 110,000; Full time

Job summary

Prochem Engineering is seeking an experienced Project Engineer – Systems Owner Engineer for syringe filling at a South Dublin biopharmaceutical facility. You will own syringe filling equipment from design through qualification and handover, leading FAT/SAT, IQ/OQ/PQ, and validation to ensure readiness for commercial operation.

The role requires a strong GMP background, aseptic processing knowledge, and experience with single-use technologies.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical, or related Engineering discipline required.
• 5+ years of bio-pharmaceutical manufacturing engineering experience.
• Experience with aseptic syringe filling systems and high-speed lines preferred.

Responsibilities

• Act as System Owner for syringe filling equipment from design through PQ and commercial operation.
• Lead equipment implementation, FAT/SAT, commissioning, 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, spare parts, and preventive programs.
• Provide technical leadership during deviation investigations and troubleshooting.
• Collaborate with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering.

Skills

Project leadership

Root cause analysis

Troubleshooting

GMP knowledge

Aseptic processing principles

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical, Electrical, Chemical Engineering

Tools

IQ/OQ/PQ knowledge

Validation lifecycle

Single-use technologies experience

Syringe filling systems experience

Job description

Prochem Engineering is seeking an experienced Project Engineer – Systems Owner Engineer for syringe filling at a South Dublin biopharmaceutical facility. You will own syringe filling equipment from design through qualification and handover, leading FAT/SAT, IQ/OQ/PQ, and validation to ensure readiness for commercial operation.

The role requires a strong GMP background, aseptic processing knowledge, and experience with single-use technologies.