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Engineering Manager – F&E Readiness

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advanced syringe filling facility. 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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Requirements:

  • 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

Nice to have:

  • 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
What we offer:
  • competitive salary
  • comprehensive Total Rewards Plan including health, financial and career development benefits

Additional Information:

Job Posted:
April 05, 2026

Work Type:
On-site work
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