Sr. Automation Engineer - Filling

<h2><b>Career Category</b></h2>Information Systems<h2></h2><h2><b>Job Description</b></h2><p><b>About Amgen Dun Laoghaire (ADL):</b><br />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.</p><p></p><p><b>About the Role:</b></p><p>The Sr Automation Engineer is a member of the ADL Plant Automation Team responsible for supporting drug product manufacturing, maintaining automation systems in a GMP environment and implementing optimisation projects.</p><p>The role is a System Owner for critical automation assets, leading troubleshooting, lifecycle management, and continuous improvement initiatives across multiple automation platforms.</p><p></p><p><b>Key Responsibilities</b></p><p>System Ownership &amp; Reliability</p><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><p>Support &amp; Troubleshooting</p><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><p>Continuous Improvement &amp; Innovation</p><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><p>Project &amp; Technology Integration</p><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><p>Safety &amp; Compliance</p><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><p></p><p><b>Preferred Qualifications and Experience:</b></p><ul><li>Bachelor’s Degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering with 5&#43; years’ experience in operations/manufacturing environment.</li><li>Background in automation design, installation, validation, lifecycle management, testing and programming.</li><li>Experience in one the following automation specialties is an advantage:<ul><li>Biopharmaceutical Formulation or Vial/Syringe Filling</li><li>Inspection or Packaging facilities</li><li>Siemens and Rockwell PLC/HMI.</li><li>iFix, InTouch, Zenon, Process Control Systems, and Rockwell FTView SCADAs.</li><li>Fieldbus systems such as ControlNet, DeviceNet, Profibus, ProfiNet, AS-I, BACnet etc.</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>Working knowledge of network architecture technologies including TCP/IP and Firewalls.</li><li>Independent, self-motivated, organised, and able to multi-task in a manufacturing environment.</li><li>Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.</li><li>Solid technical writing, and communication/presentation skills.</li><li>Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.</li><li>Travel at various times may be required to support training and vendor visits.</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.