Amgen Engineer (System Owner Component Prep & Formulation) in Dun-Laoghaire-Rathdown, Ireland

Overview:

The System Owner reports to the Engineering Manager and is responsible for all equipment related issues associated with the Formulation and Component Prep areas. The objective of the role is to be the subject matter expert and primary contact on site for the equipment and processes within the unit operations of Formulation, Component Prep and Filter Integrity Testing. 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

  • Working 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

  • Working 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/‚Äčor 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:

  • Master's degree OR

  • Bachelor's degree & 2 years of directly related experience

Relevant Experience

  • Typically 2+ years' engineering experience in an aseptic pharmaceutical environment, preferably with experience in the unit operations on Formulation, Autoclaves, Parts Washers and Filter Integrity Testing