Engineering Manager – F&E Readiness
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Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Career Category
EngineeringJob Description
Engineering Manager F&E Readiness (New Syringe Filling Facility ADL)
What you will do
Lets do this. Lets 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
- Bachelors 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.
.Required Experience:
Manager
Key Skills
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
