Amgen Specialist IS Automation Engineer (OEM) in Dun-Laoghaire-Rathdown, Ireland

Key Responsibilities

  • Ownership and administration of equipment control systems in a GMP regulated manufacturing setting

  • Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Component Preparation and Packaging areas

  • Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures

  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems

  • Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs

  • Solving complex problems, project management, lifecycle management and operational excellence

  • Develop and manage change control requests per established SOPs and processes

  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Preferred Qualifications

  • Bachelor's Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 7+ years' experience in operations/manufacturing environment

  • Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities

  • Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment specifically in the areas of Formulation, Vial/Syringe Filling, Lyophilisation and Packaging

  • Experience with Rockwell Automation PLC/SCADA/Batch, Siemens PLC/HMI, iFix, Wonderware, Elau/Kinetix Motion Control, ControlNet, DeviceNet, Profibus and OSIsoft PI Data Historian

  • Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11

  • Strong network architecture or engineering proficiencies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls

  • Solid leadership, technical writing, and communication/presentation skills

  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices

  • Experience in developing automation strategies for new product introduction and new technology deployment

  • Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans

  • Ability to influence the development of business area strategy and IT strategy where appropriate

  • Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements

  • Development and presentation of project plans to senior management

  • Day to day vendor management and contract negotiations with focus on Automation Systems Integrators and OEM suppliers

  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration

  • Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-makingTravel at various times may be required to support execution of projects