About This Role
This senior automation engineering role supports drug product manufacturing at Amgen Dun Laoghaire (ADL), maintaining automation systems in a GMP environment and implementing optimisation projects. The engineer acts as a System Owner for critical automation assets, leading troubleshooting, lifecycle management, and continuous improvement initiatives across multiple automation platforms.
Responsibilities
- Act as System Owner for automation systems in a GMP-regulated manufacturing setting, overseeing lifecycle maintenance and validation
- Manage Change Controls, Deviations, and CAPAs associated with Automation Systems
- Maintain robust system documentation, configuration control, and software versioning
- Provide on-the-floor and remote technical support to operations and engineering during production, shutdowns, and technology transfers
- Lead or support incident investigations and root cause analyses for automation-related issues
- Implement CAPAs, including software changes and updates to design documentation and SOPs
- Analyse current system designs and recommend improvements aligned with the latest technology and regulatory standards
- Champion Industry 4.0 initiatives, including data integration, advanced analytics, and digital twin technologies
- Support new product or technology introductions by performing engineering assessments, implementing automation system changes, and supporting engineering runs
- Work closely with cross-functional teams, stakeholders, and vendors to achieve common goals and deliver projects efficiently
- Promote a culture of safety and regulatory compliance across all activities
- Ensure adherence to EHS and GMP policies
Requirements
- Bachelor
- 5+ years
- Background in automation design, installation, validation, lifecycle management, testing and programming
- Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11
- Working knowledge of network architecture technologies including TCP/IP and Firewalls
- Independent, self-motivated, organised, and able to multi-task in a manufacturing environment
- Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
- Solid technical writing, and communication/presentation skills
- Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals
- Ability to travel at various times to support training and vendor visits
Nice to have:
- Experience in one of the following automation specialties: Biopharmaceutical Formulation or Vial/Syringe Filling; Inspection or Packaging facilities; Siemens and Rockwell PLC/HMI; iFix, InTouch, Zenon, Process Control Systems, and Rockwell FTView SCADAs; Fieldbus systems such as ControlNet, DeviceNet, Profibus, ProfiNet, AS-I, BACnet etc.
