Senior Packaging Systems Engineer - GMP & Automation Owner

Amgen; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking a Senior Packaging Engineer to join the Inspection & Packaging Engineering team to support the plant's expansion and production capability on site. The role involves developing and improving manufacturing processes, equipment, and products, applying engineering expertise to solve complex problems and lead technical projects.

The successful candidate will report to the Engineering Manager, be proficient in statistical tools and continuous improvement, and have

Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical or Mechatronic preferred).
• Senior level experience of providing technical solutions in the packaging, inspection, medical device or pharmaceutical sector.
• Demonstrated solid leadership, with the ability to build teams and operate across functional boundaries.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Demonstrated experience of vendor management and contract negotiations with focus on equipment suppliers, SLA’s and continuous supplier performance.
• Significant experience large project related activities including GMP qualification experience.

Responsibilities

• Support a safe working environment by complying with EH&S practices and regulations.
• Ownership of equipment/systems in a GMP manufacturing setting.
• Monitor day-to-day performance of assigned systems and report on performance and issue resolution plans.
• Data trend analysis of performance to identify trends and proactive improvements.
• Lead system improvements and develop specifications, engineering documents and SOPs.
• Ensure GMP documentation accuracy throughout equipment lifecycle (RFDs, URS, etc.).
• Lead root cause analyses, investigations and troubleshooting for equipment/systems.
• Collaborate with Process & Quality Team on investigations, Non-Conformance and CAPA closure.
• Oversee project work with upgrades and new equipment, including FAT/SAT/IOQ protocols.
• Identify critical spare parts and plan outages with available resources.
• Maintain a plan for future improvements and downtime scheduling.

Skills

Leadership

Change control

Vendor management

GMP qualification

Packaging experience

Education

Bachelor’s degree in engineering (Mechanical, Electrical or Mechatronic preferred)

Job description

Amgen Dun Laoghaire (ADL) is seeking a Senior Packaging Engineer to join the Inspection & Packaging Engineering team to support the plant's expansion and production capability on site. The role involves developing and improving manufacturing processes, equipment, and products, applying engineering expertise to solve complex problems and lead technical projects.

The successful candidate will report to the Engineering Manager, be proficient in statistical tools and continuous improvement, and have