Process Engineer

PE Global is currently recruiting a Process Engineer for a leading multi-national Biotech client based in Dun Laoghaire.

This is an initial 12-month contract position working a hybrid schedule of 3 days onsite and 2 days remote, this may change based on business needs. This role is for an experienced Engineer to lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion.

ROLE:

• Act as System Owner (SO) for syringe filling equipment from design through to PQ and commercial operation.
• SO 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 Amgen 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.

REQUIREMENTS:

• Bachelor’s Degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in biopharmaceutical 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 desirable.
• Demonstrated ability to lead complex equipment projects from design through operational readiness.
• Strong troubleshooting and root cause analysis capability.

Must-Have

• 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.

Preferable/Nice-to-Have

• SME experience in syringe or vial filling/packaging.
• Experience from pharmaceutical, medical device, food & beverage, or other highly automated, regulated manufacturing environments.
• Understanding of operator-equipment interactions, maintenance, reliability, KPI monitoring, deviation handling, and continuous improvement.
• Candidates with cross-industry engineering backgrounds will be considered.
• Operational readiness mindset is critical: handover should include SOPs, training, and maintenance plans well-developed.
• Previous pharma experience is not essential—transferable engineering skills and mindset more important

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 86 3514962 or alternatively send an up-to-date CV to sean.molloy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***