Equipment Process Engineer – GMP Automation

Amgen SA; Dún Laoghaire; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Total Rewards Plan

Career development

On-site amenities

Job summary

Amgen Dun Laoghaire (ADL) is seeking an Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic Drug product filling on site. This 37,000 square metre plant focuses on Formulation, Vial/Syringe Filling, Lyophilisation and Packaging, with an emphasis on equipment performance and lifecycle management.

You will report to the Engineering Lead and apply statistical analysis and continuous improvement methods to drive reliability, preventive maintenance and

Qualifications

• Bachelor's degree in Engineering or related field (Mechanical/Manufacturing/Mechatronics/Electrical/Chemical) required.
• Experience in manufacturing in a regulated environment is essential.
• Experience with statistical analysis and continuous improvement in a GMP context is desirable.

Responsibilities

• Ownership of equipment/systems in a GMP manufacturing setting that support Drug Product processes.
• Monitor day-to-day performance and analyze trends to preempt issues.
• Develop specifications, engineering documents and SOPs to improve equipment reliability and performance.
• Lead root cause analysis, investigations and CAPA when equipment issues arise.
• Manage change control requests and support new product or technology introductions.
• Collaborate with cross-functional teams and vendors to minimize downtime and optimize maintenance.

Skills

Statistical analysis

Continuous improvement

Mechanical/electro-mechanical systems

Problem solving

Education

Bachelor's degree in Engineering

Tools

Statistical analysis tools

Automation systems

Job description

Amgen Dun Laoghaire (ADL) is seeking an Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic Drug product filling on site. This 37,000 square metre plant focuses on Formulation, Vial/Syringe Filling, Lyophilisation and Packaging, with an emphasis on equipment performance and lifecycle management.

You will report to the Engineering Lead and apply statistical analysis and continuous improvement methods to drive reliability, preventive maintenance and