Senior Project Engineer

Recruitment by Aphex; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Recruitment by Aphex is seeking a System Owner Engineer to lead the lifecycle management of automated syringe inspection systems in a GMP fill-finish environment. The role focuses on vision systems, reject mechanisms, and optical inspection performance, from installation through validation.

You will own performance metrics, support inspection recipe development, and drive maintenance planning to ensure readiness and reliability of highly automated equipment.

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Electrical, Automation, or related discipline).
• 5+ years' experience in biopharmaceutical manufacturing.
• Understanding of particulate detection, cosmetic defect inspection, and container closure integrity.
• Experience supporting equipment validation and data integrity compliance.
• Strong analytical and problem-solving skills.
• Self-starter with the ability to work autonomously.
• Hands-on experience with highly automated equipment.
• Experience taking equipment from project to operational phase.
• Able to manage operations readiness, training, and maintenance planning.

Responsibilities

• Act as System Owner (SO) for high speed automated syringe inspection systems.
• SO during FAT/SAT, commissioning, qualification, and validation activities.
• Ensure GMP, Annex 1, and data integrity compliance.
• Own system performance metrics including False reject rates, Detection capability, OEE performance.
• Support inspection recipe development and optimisation.
• Develop maintenance and lifecycle strategies for inspection equipment.
• Lead troubleshooting and root cause investigations for inspection failures.

Job description

System Owner Engineer - Syringe Inspection Systems

Purpose: Seeking a System Owner Engineer to support the installation, validation, and lifecycle management of automated syringe inspection systems within a GMP fill-finish facility expansion. This role will focus on vision systems, reject mechanisms, and inspection performance optimisation.

Key Responsibilities

• Act as System Owner (SO) for high speed automated syringe inspection systems.
• SO during the FAT/SAT, commissioning, qualification, and validation activities.
• Ensure compliance with GMP, Annex 1, and data integrity requirements.
• Own system performance metrics including: False reject rates, Detection capability, OEE performance
• Support inspection recipe development and optimisation.
• Develop maintenance and lifecycle strategies for inspection equipment.
• Lead troubleshooting and root cause investigations for inspection failures.

Basic Qualifications / Experience

• Bachelor's Degree in Engineering (Mechanical, Electrical, Automation, or related discipline).
• 5+ years' experience in biopharmaceutical manufacturing.
• Understanding of particulate detection, cosmetic defect inspection, and container closure integrity.
• Experience supporting equipment validation and data integrity compliance.
• Strong analytical and problem-solving skills.
• Strong engineering knowledge and aptitude (not limited to pharma).
• Self-starter with strong motivation; able to work autonomously
• Experience taking equipment from project to operational phase.
• Direct hands‑on experience with highly automated equipment.
• Able to manage and support operational readiness, training, and maintenance planning.

Experience with:

• Automated visual inspection systems (AVI)
• Vision systems
• High-speed packaging or inspection lines