Sr. Automation Engineer Utilities

Career Category

Job 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 Amgens 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:

• Bachelors 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.