Description
**About Amgen Dun Laoghaire (ADL):**
Amgen is a global biotechnology leader committed to discovering, developing, and delivering innovative human therapeutics. Our 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. We foster a culture of continuous improvement and innovation, striving to improve health outcomes and ensure the continuity of supply for our medicines to over 50 countries worldwide.
**About the Role:**
The Sr. Automation Engineer (Utilities) is a member of the ADL Plant Automation Team and supports the day-to-day operation, reliability, and compliance of Amgen’s utility and building automation systems.
The role is a System Owner for both Siemens Desigo CC and Siemens PLC systems, ensuring uptime, compliance, and continuous improvement in a GMP-regulated environment.
**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-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.
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 Mechatronic Engineering, Automation Engineering, Control 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 the following automation specialties is an advantage:
+ Building Management Systems (Siemens Desigo)
+ Siemens S7-300/400/1200/1500 PLCs.
+ Siemens HMIs.
+ Siemens Desigo PXC series
+ Siemens Desigo CC
+ Profinet, Profibus, Modbus TCP, BACnet, OPC UA
+ SQL Database
+ Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.
+ Support integration of utilities data into AVEVA PI System and analytics dashboards. Analyse trends and historian data to identify reliability and performance improvements.
+ Working knowledge of network architecture technologies including TCP/IP and Firewalls.
+ Work independently, stay organized, and manage several tasks in a busy manufacturing setting.
+ Be a supportive team player who values teamwork and collaboration.
+ Strong technical writing, communication, and presentation skills.
+ Build good relationships and work with teams from different areas to reach shared goals.
+ Travel at various times may be required to support training and vendor visits.
