Sr. Automation Engineer - Packaging

Amgen; Leinster; On-site; EUR 85,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Sr. Automation Engineer to join the Plant Automation Team. You will own automation assets in a GMP manufacturing setting, lead lifecycle maintenance, validation, and change controls to support drug product operations.

You will collaborate with operations, engineering, and vendors to deliver improvements, digitalisation, and Industry 4.0 initiatives, including data integration and digital twins.

Qualifications

• Bachelor’s degree in automation or life science engineering.
• 5+ years in operations/manufacturing environment.
• Experience with automation design, validation, lifecycle management, testing and programming.

Responsibilities

• Act as System Owner for automation systems in GMP manufacturing, overseeing lifecycle maintenance and validation.
• Manage Change Controls, Deviations, and CAPAs for Automation Systems.
• Provide on-the-floor and remote technical support during production, shutdowns, and tech transfers.
• Lead or support incident investigations and root cause analyses for automation issues.
• Champion CAPAs, software changes, and SOP updates; drive Industry 4.0 data integration and analytics.

Skills

Automation Engineering

Electrical Engineering

Biotech Engineering

PLC/HMI

Rockwell FTView

iFix/InTouch

Process Control Systems

GAMP lifecycle

21 CFR Part 11

Team collaboration

Technical writing

Stakeholder management

TCP/IP networking

Travel willingness

Education

Bachelor’s Degree in Automation/Electrical/CS/Biotech

Tools

Siemens PLC

Rockwell PLC

FTView SCADA

iFix

InTouch

Zenon

Process Control Systems

TCP/IP networking

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.

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 minimum 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.
  • iFix, InTouch, Zenon, Process Control Systems, and Rockwell FTView SCADAs.
  • Fieldbus systems such as ControlNet, DeviceNet, Profibus, ProfiNet, 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.