Senior Process Engineer – Syringe Fill-Finish (Hybrid)

PE Global

Dún Laoghaire-Rathdown

Hybrid

EUR 70,000 - 95,000

Full time

2 days ago

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Job summary

PE Global is recruiting a Process Engineer for a leading multinational Biotech client in Dun Laoghaire. This 12-month contract offers a hybrid schedule: 3 days onsite and 2 days remote, focusing on leading the implementation and operational readiness of syringe filling equipment and single-use systems as part of a major site expansion.

You will own equipment from design through PQ and operation, drive manufacturing readiness, ensure GMP/regulatory compliance, and collaborate across

Qualifications

5+ years’ experience in biopharmaceutical manufacturing engineering.
Experience leading equipment projects from design through readiness.
Knowledge of GMP, regulatory expectations and Annex 1.
Aseptic syringe filling systems knowledge is preferred.
Strong problem-solving and RCA capabilities.

Responsibilities

Act as System Owner for syringe filling equipment from design through PQ and operation.
Lead FAT/SAT, commissioning, IQ/OQ/PQ, and validation activities.
Drive manufacturing readiness, start-up, and handover to operations.
Ensure GMP/regulatory compliance and site expansion readiness.
Develop maintenance strategies and lifecycle asset plans.
Provide technical leadership during deviations and optimization.
Partner with Manufacturing, Quality, Automation, Validation, EHSS and Global Engineering.