Engineering Manager – F&E Readiness

Career Category

Engineering

Job 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.

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