Sr. Automation Engineer – Filling at Amgen
Location: Dublin, County Dublin, Ireland
About Amgen
Amgen is a global biotechnology leader committed to discovering, developing, and delivering innovative human therapeutics. The Dun Laoghaire site is a state‑of‑the‑art aseptic drug product operations facility specializing in secondary manufacturing activities, including formulation, vial/syringe filling, lyophilisation, inspection, and packaging. The culture encourages continuous improvement and innovation to improve health outcomes worldwide.
About the Role
The Sr. Automation Engineer is a member of the ADL Plant Automation Team responsible for supporting drug product manufacturing, maintaining automation systems in a GMP environment, and implementing optimisation projects. The role is a System Owner for critical automation assets, leading troubleshooting, lifecycle management, and continuous improvement initiatives across multiple automation platforms.
Key Responsibilities
System Ownership & Reliability
* 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.
Support & Troubleshooting
* Provide on‑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.
Continuous Improvement & Innovation
* 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.
Project & Technology Integration
* 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.
Safety & Compliance
* Promote a culture of safety and regulatory compliance across all activities.
* Always ensure adherence to EHS and GMP policies.
Preferred Qualifications and Experience
* Bachelor’s Degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related life‑science engineering with 5+ years’ experience in operations/manufacturing environment.
* Background in automation design, installation, validation, lifecycle management, testing and programming.
* Experience in one of the following automation specialties is an advantage:
o Biopharmaceutical Formulation or Vial/Syringe Filling
o Inspection or Packaging facilities
o Siemens and Rockwell PLC/HMI
o iFix, InTouch, Zenon, Process Control Systems, and Rockwell FTView SCADAs
o Fieldbus systems such as ControlNet, DeviceNet, Profibus, ProfiNet, AS‑I, BACnet, etc.
o Knowledge of GAMP software development lifecycle, ANSI/ISA‑S88 and S95 industry standards, 21 CFR Part 11 and Annex 11
o Working knowledge of network architecture technologies including TCP/IP and Firewalls
o Independent, self‑motivated, organised, and able to multi‑task in a manufacturing environment
o Team player, prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making
o Solid technical writing, communication/presentation skills
o Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals
o Travel at various times may be required to support training and vendor visits
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