Amgen Engineer System Owner in Dublin, Ireland

Engineer (System Owner)

Amgen Dun Laoghaire - Dublin

Overview:

The System Owner reports to the Engineering Manager and is responsible for all equipment related issues associated with specific unit operations including Vial / Syringe Filling, Formulation, Component Prep and / or Lyophilisation. The objective of the role is to be the subject matter expert and primary contact on site for the equipment and processes associated with the assigned unit operation. Responsibilities include:

  • Problem solving and troubleshooting all equipment issues and minimizing unscheduled equipment downtime

  • Strong knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment reliability technology. Monitors equipment performance and develops and maintains metrics in relation to equipment reliability.

  • Experience in investigation of non-conformances, development of corrective and preventive actions and generation and implementation of change controls

  • Works in a collaborative manner with the Maintenance Manager and Technicians to ensure preventative maintenance program is effective

  • Responsible for Preventative Maintenance budget for equipment and spare parts inventory optimization

  • Works in a collaborative manner with Manufacturing Operations on yield and quality improvement projects. Applies mature engineering knowledge in planning and conducting projects

  • Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance

  • Interacts with Maintenance Technicians, Project Engineers and Vendors to perform equipment upgrade and/​or retrofits.

  • Is a champion for safe working practices and safety initiatives within their functional area

  • Contribute and assist with Corporate and other regulatory bodies during company audits

  • Working knowledge of Automation systems and processes such as Delta-V, BMS, or PLC

  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields

Basic Qualifications:

  • Bachelor's degree & 3 years of directly related experience

Relevant Experience

  • Typically 2+ years engineering experience in an aseptic pharmaceutical environment, preferably with experience in the unit operations of Sterile Filling, Formulation, Lyophilisation, Autoclaves, Parts Washers or Filter Integrity Testing