Amgen

Biotechnology

Sr.AutomationEngineer

Ireland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Sr. Automation Engineer at Amgen. Skills: Automation systems, GMP environment, PLC/HMI, SCADA. Act as System Owner for automation systems. Manage Change Controls, Deviations, and CAPAs”

What You'll Achieve.

Improve health outcomes; Ensure continuity of supply

Industry & Context.

Biotechnology
Problems you'll solve

Troubleshooting; Incident investigations; Root cause analyses

Eligibility Requirements

Travel may be required, Vendor visits

What They're Looking For.

Must Have

5+ years’ experience in operations/manufacturing environment, Automation design, Installation, Validation, Lifecycle management, Testing, Programming

Nice to Have

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., GAMP software development lifecycle, ANSI/ISA-S88, S95 industry standards, 21 CFR Part 11, Annex 11, Network architecture technologies including TCP/IP and Firewalls

What You'll Do.

Act as System Owner for automation systems

Manage Change Controls

Maintain system documentation

Provide technical support to operations

Lead incident investigations

Analyse system designs

Champion Industry 4.0 initiatives

Support new product introductions

Promote safety and compliance

Ensure adherence to EHS and GMP policies

How You'll Work.

Team & Collaboration

Work closely with cross-functional teams; Collaborating with teams from different departments

Communication Scope

Communication/presentation skills

Process & Methodology

Lifecycle management, Project management

Full Job Description

## **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, a

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