An established biopharmaceutical manufacturing operation in Dublin is seeking a hands-on Site Automation Engineer to support the reliability, performance and compliance of its manufacturing control systems.
Based within the Operational Technology (OT) team, you will work closely with live production in a regulated Active Pharmaceutical Ingredient (API) manufacturing environment.
This is an excellent opportunity for an engineer who enjoys practical problem-solving, investigating recurring faults and improving automation systems. Alongside day-to-day production support, you will contribute to system upgrades, equipment improvements and engineering projects that help maintain safe, reliable and compliant manufacturing operations.
Key Responsibilities
- Provide hands-on automation support to manufacturing operations, resolving control-system issues that affect production.
- Troubleshoot PLC, HMI, SCADA, DCS, batch-control and building management systems, including associated hardware and software.
- Conduct root-cause investigations and contribute to incident reviews, deviations, non-conformances and Corrective and Preventive Actions (CAPA).
- Support automation system upgrades, replacements and continuous improvement initiatives.
- Deliver small-to-medium engineering projects to improve system reliability and manufacturing performance.
- Prepare and maintain engineering specifications, technical documentation, Standard Operating Procedures (SOPs) and work instructions.
- Manage system changes through formal change-control processes and support validation and GxP computerised-system lifecycle activities.
- Maintain system reliability, data integrity and compliance with quality, safety and environmental requirements.
- Collaborate with Manufacturing, Maintenance, Engineering, Quality, Validation and EHS teams.
- Participate in the OT team's out-of-hours on-call rota.
- A degree or relevant qualification in Automation, Controls, Electrical Engineering or a related engineering discipline.
- Practical experience supporting automation or process-control systems within pharmaceutical, biopharmaceutical, API or another regulated manufacturing environment.
- Strong hands-on PLC troubleshooting skills, ideally with Siemens S7.
- Experience with SCADA/HMI and/or DCS platforms in a live manufacturing environment.
- A methodical approach to fault-finding, root-cause analysis and resolving production issues.
- An understanding of GMP, quality systems, validation, change control and EHS requirements.
- Strong communication skills and the ability to work effectively with production and technical teams.
Desirable Technical Experience
Experience with the following technologies, systems or standards would be advantageous:
- Control systems: Siemens PCS 7, WinCC, iFIX, Wonderware InTouch and batch systems.
- Industrial infrastructure: Historians, databases, OT networking, TCP/IP, routing and switching, Active Directory and network monitoring.
- GMP and validation: GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GxP computerised-system lifecycle requirements.
- Engineering standards and processes: ISA-88, ISA-95, deviation management, change control and CAPA.