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.

What you will do

• 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.

What we expect of you

• 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 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.
• Working knowledge of network architecture technologies including TCP/IP and Firewalls.

Must-Have Skills

• 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.

Good-to-Have Skills

• Build good relationships and work with teams from different areas to reach shared goals.

Compensation

7-300