Sr. Automation Engineer - Filling at Amgen

Career Category

Information Systems:

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 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-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 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 the following automation specialties is an advantage:

• Biopharmaceutical Formulation or Vial/Syringe Filling

• Inspection or Packaging facilities

• Siemens and Rockwell PLC/HMI.

• i Fix, In Touch, Zenon, Process Control Systems, and Rockwell FTView SCADAs.

• Fieldbus systems such as Control Net, Device Net, Profibus, Profi Net, AS-I, BACnet etc.

• Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.

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

• Independent, self-motivated, organised, and able to multi-task in a manufacturing environment.

• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

• Solid technical writing, and communication/presentation skills.

• Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.

• Travel at various times may be required to support training and vendor visits.

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