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Amgen Inspection Engineer - System Owner - FTC in Dublin, Ireland

Overview :

This position will be part of the Inspection team and will be responsible for set up of the maintenance system for automated and manual inspection lines in that area. The Engineer reports to the Engineering Manager, the candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and associated automation systems.

Responsibilities include:

The chosen candidate would typically be accountable for the following activities (but not exclusively);

  • Monitoring of day to day performance of their assigned system.

  • Measuring and maximizing the uptime of their system.

  • Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.

  • Ensuring the preventive maintenance schedule for their system is successfully implemented.

  • Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained.

  • The definition and scoping of all process improvement activities relating to the system.

  • Anticipating, solving or escalating problems as appropriate.

  • All design reviews associated with equipment purchases.

  • Troubleshooting of performance trends.

  • Risk assessments and mitigation projects relating to system performance.

  • Support of new product introduction and introduction of new equipment.

  • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.

  • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.

  • Continuous improvement programs and all performance improvement projects.

  • Reviewing and approval of changes to operating procedures and the change control process relating to the system.

  • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high system performance.

  • Working in a collaborative manner within the Process Teams structure and contributes to investigations, NC and CAPA closure.

Basic Qualifications:

  • Bachelors degree in Engineering (Mechanical, Electrical or Chemical)

  • Senior level experience providing solutions and support in the biotechnology, pharmaceutical industries.

  • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.

  • Significant relevant industrial project experience

Preferred Experience

  • Typically 5+ years engineering experience in a drug product environment

  • Experience supporting packaging lines essential. Automation/ serialisation and vision system experience an advantage.

  • Significant experience large project related activities including GMP qualification experience.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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