Sr. Engineer System Owner

Career Category

Job Description

The Senior Engineer at Amgen is responsible for developing and improving manufacturing processes, equipment, and products. They apply their engineering expertise to solve complex problems, lead technical projects, and collaborate with cross-functional teams to drive innovation and efficiency within the company.

Senior Engineer – System Owner

Amgen Dun Laoghaire - Dublin

Overview:

This position will be part of the filling group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Senior Engineering Manager, Maintenance. 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 introductions 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 or           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 8+ years engineering experience in an aseptic pharmaceutical environment

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