Amgen Sr. Engineer – System Owner in Dublin, Ireland
This position will be part of the Site F&E (Facilities & Engineering) group and the successful candidate will be System Owner for certain Equipment Systems on site within the group. He/She reports to the Sr. Manager - Engineering. The candidate will have knowledge and proficiency in a variety of areas, including GMP and nGMP systems, the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and their associated automation systems & interfaces.
The chosen candidate would typically be accountable for the following activities (but not exclusively);
Lead for RCAs, investigations, deviations for any operational issues related to the Systems owned.
Liaison with Manufacturing, QA and Labs on performance issues and with EHS on Safety and Environmental issues
Being the site contact (SME Subject Matter Expert) for external and regulatory audits.
Rolling out training on systems for which the candidate is the designated SME / System Owner
Driving Continuous Improvement in the performance elements of Systems owned
Actively engaging in Work Centre Teams, as the SME for Equipment and Systems owned
System Ownership responsibilities would include:
Measuring and maximizing the uptime of their systems.
Monitoring of day to day performance of their assigned systems.
Data trend analysis of all performance aspects of their systems and equipment to identify and proactively manage performance trends, including anticipating, solving or escalating problems as appropriate.
Troubleshooting of performance trends.
Risk assessments and mitigation projects relating to system performance.
Ensuring the preventative maintenance schedule for their systems is successfully implemented.
Driving predictive maintenance methodologies and best practice maintenance governance
Ensuring that critical spare parts lists for their system are identified and appropriate levels of spares are maintained.
The definition and scoping of all improvement activities relating to their systems
All design reviews associated with equipment purchases / changes to their systems
All QMTS Triage sessions, investigations, NCs and CAPAs associated with their systems, including the ownership and completion of any RCAs
The development and execution of FAT, SAT and IOQ protocols
Representing F&E on site based teams involved in implementing new technology, products or business processes to the site
Reviewing and approval of changes to operating procedures and the change control process relating to their systems
Owning and completion of any CMMS administrative WOs associated with their systems.
• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical).
• Experience in the Pharmaceutical or Biotechnology industries, in a direct or supportive Equipment Owner role, operating equipment and troubleshooting all types of utility or process systems, including electrical, mechanical and instrumentation experience, preferred.
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 diseases, 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.