<h2>Career Category</h2>Information Systems<h2></h2><h2>Job Description</h2>About Amgen Dun Laoghaire (ADL): Amgen is a global biotechnology leader committed to discovering, developing, and delivering innovative human therapeutics. Our Dun Laoghaire site is a state-of-the-art aseptic drug product operations facility specializing in secondary manufacturing activities, including Formulation, Vial/Syringe Filling, Lyophilisation, Inspection and Packaging. We foster a culture of continuous improvement and innovation, striving to improve health outcomes and ensure the continuity of supply for our medicines to over 50 countries worldwide.About the Role:The Sr. Automation Engineer (Utilities) is a member of the ADL Plant Automation Team and supports the day-to-day operation, reliability, and compliance of Amgen’s utility and building automation systems.The role is a System Owner for both Siemens Desigo CC and Siemens PLC systems, ensuring uptime, compliance, and continuous improvement in a GMP-regulated environment.  Key ResponsibilitiesSystem Ownership &amp; Reliability<ul><li>Act as System Owner for automation systems in a GMP-regulated manufacturing setting, overseeing lifecycle maintenance and validation.</li></ul><ul><li>Manage Change Controls, Deviations, and CAPAs associated with Automation Systems.</li><li>Maintain robust system documentation, configuration control, and software versioning.</li></ul>Support &amp; Troubleshooting<ul><li>Provide on-the-floor and remote technical support to operations and engineering during production, shutdowns, and technology transfers.</li><li>Lead or support incident investigations and root cause analyses for automation-related issues.</li></ul>Continuous Improvement &amp; Innovation<ul><li>Implement CAPAs, including software changes and updates to design documentation and SOPs.</li><li>Analyse current system designs and recommend improvements aligned with the latest technology and regulatory standards.</li><li>Champion Industry 4.0 initiatives, including data integration, advanced analytics, and digital twin technologies.</li></ul>Project &amp; Technology Integration<ul><li>Support new product or technology introductions by performing engineering assessments, implementing automation system changes, and supporting engineering runs.</li><li>Work closely with cross-functional teams, stakeholders, and vendors to achieve common goals and deliver projects efficiently.</li></ul>Safety &amp; Compliance<ul><li>Promote a culture of safety and regulatory compliance across all activities.</li><li>Always Ensure adherence to EHS and GMP policies.</li></ul>Preferred Qualifications and Experience:<ul><li>Bachelor’s degree in Mechatronic Engineering, Automation Engineering, Control Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment.</li><li>Background in automation design, installation, validation, lifecycle management, testing and programming.</li><li>Experience in the following automation specialties is an advantage:<ul><li>Building Management Systems (Siemens Desigo)</li><li>Siemens S7-300/400/1200/1500 PLCs.</li><li>Siemens HMIs.</li><li>Siemens Desigo PXC series</li><li>Siemens Desigo CC</li><li>Profinet, Profibus, Modbus TCP, BACnet, OPC UA</li><li>SQL Database</li></ul></li></ul><ul><li>Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.</li><li>Support integration of utilities data into AVEVA PI System and analytics dashboards.  Analyse trends and historian data to identify reliability and performance improvements.</li></ul><ul><li>Working knowledge of network architecture technologies including TCP/IP and Firewalls.</li></ul><ul><li>Work independently, stay organized, and manage several tasks in a busy manufacturing setting.</li><li>Be a supportive team player who values teamwork and collaboration.</li><li>Strong technical writing, communication, and presentation skills.</li><li>Build good relationships and work with teams from different areas to reach shared goals.</li><li>Travel at various times may be required to support training and vendor visits.</li></ul>.