Specialist IS Automation Engineer (OEM)
Amgen Inc
Dublin, Dublin
6d ago

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-making
  • Travel at various times may be required to support execution of projects

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