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