Aseptic Drug Equipment Process Engineer

Amgen; Leinster; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Total rewards plan

Annual bonus

Medical insurance

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 role will focus on performance of drug product equipment, reporting to the Engineering Lead and covering mechanical, electro-mechanical and automation systems.

You will contribute to reliability and lifecycle management, drive continuous improvement initiatives, support root-cause analysis and change control, and collaborate

Qualifications

• Bachelor's degree in Engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical).
• Manufacturing experience in a regulated environment.
• Experience in the use of statistical analysis tools and continuous improvement methodologies.
• Problem solving and applied engineering skills relating to mechanical, electro-mechanical and automation systems.

Responsibilities

• Ownership of equipment/systems in a GMP manufacturing setting that support Drug Product processes.
• Monitoring of day-to-day performance and trend analysis to identify improvement opportunities.
• Support system improvements, development of specifications, engineering documents and SOPs.
• Assist with root cause analysis, incident investigations and CAPA closures.
• Develop and manage change control requests and support new product introductions.
• Communicate with stakeholders and work collaboratively within cross-functional teams.

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 role will focus on performance of drug product equipment, reporting to the Engineering Lead and covering mechanical, electro-mechanical and automation systems.

You will contribute to reliability and lifecycle management, drive continuous improvement initiatives, support root-cause analysis and change control, and collaborate