About this role
Career Category
Information SystemsJob 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.
Other facts
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
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What you'll do
- The Sr. Automation Engineer is responsible for overseeing the operation, reliability, and compliance of utility and building automation systems in a GMP-regulated environment. Key tasks include managing system documentation, providing technical support, and implementing continuous improvements.
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