GMP Aseptic Equipment Process Engineer

Amgen; Dublin; Hybrid; EUR 56,000 - 76,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking an Equipment Process Engineer to join the Drug Product Engineering team to support commercial aseptic drug product filling on site in Dun Laoghaire, Ireland.

The role involves ownership of equipment and systems in a GMP environment, applying statistical analysis, continuous improvement, and problem solving to ensure reliable operation and lifecycle management of the equipment.

Qualifications

• Bachelor’s degree in Engineering (Mechanical/Manufacturing/Mechatronics/Electrical/Chemical).
• Experience in a regulated manufacturing environment.
• Experience with statistical analysis tools and continuous improvement.
• Strong problem-solving and applied engineering skills for mechanical/electro-mechanical systems.

Responsibilities

• Own equipment/systems in GMP drug product manufacturing.
• Monitor day-to-day performance and analyze trends.
• Develop specifications, documents, and SOPs.
• Lead root cause analysis and CAPA for equipment issues.
• Plan maintenance and support vendor procurement for parts.

Skills

Statistical analysis

Continuous improvement

Problem solving

Electrical/mechanical systems

Education

Bachelor's degree in Engineering

Job description

Amgen Dun Laoghaire (ADL) is seeking an Equipment Process Engineer to join the Drug Product Engineering team to support commercial aseptic drug product filling on site in Dun Laoghaire, Ireland.

The role involves ownership of equipment and systems in a GMP environment, applying statistical analysis, continuous improvement, and problem solving to ensure reliable operation and lifecycle management of the equipment.