Engineering Manager – F&E Readiness

<h2><b>Career Category</b></h2>Engineering<h2></h2><h2><b>Job Description</b></h2><p><b>Engineering Manager – F&amp;E Readiness (New Syringe Filling Facility, ADL)</b></p><p><b>What you will do</b></p><p><b>Let’s do this. Let’s change the world.</b></p><p>Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advanced syringe filling facility that will set new standards for operational excellence, reliability and performance across the network. We are seeking an <b>Engineering Manager – F&amp;E Readiness to Commercial production</b> to join the project during the Detailed Design phase and play a pivotal role in shaping the future operation of this facility.</p><p></p><p>This position will partner closely with the project leadership team to ensure that Facility &amp; Engineering (F&amp;E) requirements are fully defined, integrated and delivered through design, construction, commissioning and into commercial operations.</p><p></p><p>This is a unique opportunity to influence the design and long-term performance of one of the most technologically advanced drug product plants in the Amgen network. The successful candidate will initially operate as a hands-on individual contributor while building and leading a new high-performing engineering team to support start-up through to sustained operations.</p><p></p><p><b>Why this role stands out</b></p><p><b>This is not a typical engineering role. You will:</b></p><ul><li>Shape the design and long-term performance of a flagship facility</li><li>Build an engineering organisation from the ground up</li><li>Define how F&amp;E operates in one of the most advanced fill/finish plants in the network</li></ul><div></div><p><b>Key Responsibilities:</b></p><p><b>Project &amp; Design Phase Leadership</b></p><ul><li>Act as the F&amp;E representative within the capital project team, ensuring site requirements are embedded in facility and equipment design.</li><li>Provide technical input and review of design deliverables (layouts, P&amp;IDs, URS, specifications, automation strategies, maintenance concepts).</li><li>Ensure alignment with Amgen global standards, corporate blueprints and site operational requirements.</li><li>Partner with Global Engineering, CQV, Automation, Quality and Operations to ensure a fully integrated and operable facility design.</li><li>Identify and mitigate operability, maintainability and reliability risks early.</li></ul><p></p><p><b>F&amp;E Readiness &amp; Strategy</b></p><ul><li>Define and develop the F&amp;E readiness strategy, including:<ul><li>Maintenance strategy and asset lifecycle plans</li><li>Spare parts and criticality assessments</li><li>Reliability and performance frameworks (OEE, predictive maintenance)</li></ul></li><li>Establish systems to ensure equipment reliability and lifecycle ownership aligned with site expectations.</li><li>Drive implementation of predictive and preventative maintenance philosophies from design through operation.</li></ul><p></p><p><b>Project Execution Support</b></p><ul><li>Support project delivery across design, construction, commissioning and qualification, ensuring smooth transition to operations.</li><li>Lead or support change control, deviation management, and technical investigations during project execution.</li><li>Coordinate with vendors and contractors to ensure technical solutions meet operational and compliance requirements.</li></ul><p></p><p><b>Operational Readiness</b></p><ul><li>Develop and implement:<ul><li>Engineering procedures and SOPs</li><li>Maintenance programs and CMMS structures</li><li>Engineering documentation and standards</li></ul></li><li>Ensure inspection readiness, regulatory compliance and audit preparedness from pre-startup onward.</li><li>Support new technology introduction and start-up activities including engineering runs and performance verification.</li></ul><p></p><p><b>Team Development &amp; Leadership</b></p><ul><li>Build and lead a new engineering team supporting syringe filling operations.</li><li>Define organisation structure, roles, and capability requirements to support commercial manufacturing.</li><li>Develop engineering talent, SMEs and long-term capability within F&amp;E.</li><li>Foster a culture of safety, collaboration, accountability and CI.</li></ul><p><b>Cross-functional Collaboration</b></p><ul><li>Work closely with Manufacturing, Quality, Validation, Automation, Supply Chain and Global Engineering to deliver project and site goals.</li><li>Represent F&amp;E in project governance, risk reviews and site leadership forums.</li></ul><div></div><p><b>Preferred Qualifications and experience</b></p><ul><li>Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline)</li><li>Experience (typically 5&#43; years) in engineering roles within a cGMP biopharmaceutical manufacturing environment</li><li>Experience in developing strategies for new product introduction and new technology deployment</li><li>Strong knowledge of, Equipment lifecycle management, Maintenance and reliability systems, GMP compliance, validation, and regulatory expectations</li><li>Proven ability to lead, build and develop teams, including working cross-functionally and managing complex stakeholder environments</li><li>Project management, problem-solving and decision-making capability</li><li>Excellent communication and technical writing skills</li></ul><ul><li>Experience in syringe/vial filling, aseptic processing or advanced drug product technologies</li><li>Experience with digital / Industry 4.0 / advanced automation systems</li><li>Record of driving continuous improvement and operational excellence</li></ul><div></div><p><b>Thrive – What you can expect of us</b></p><p>In addition to a competitive salary, Amgen offers a comprehensive Total Rewards Plan including health, financial and career development benefits. We are committed to fostering a collaborative environment where innovation thrives and employees can build meaningful, long-term careers.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.