Summary:
Our client, a leading biopharmaceutical company based in North Wicklow, is seeking an Automation Engineer to join their Technical Services team. The successful candidate will act as the SME for manufacturing control systems, operational technology, machine automation, and digitalisation. This role involves ensuring the availability, compliance, and performance of site automation systems while supporting continuous improvement and global automation initiatives.
Responsibilities:
* Act as system administrator for automation systems, monitoring performance and ensuring maximum uptime.
* Manage system user access, backup, and restore processes.
* Troubleshoot and implement corrective actions, collaborating with vendor technical support when required.
* Support routine system patching programs and implement small projects to optimise system performance.
* Participate or lead investigations related to control system deviations and ensure proper documentation.
* Support site automation and digitalisation projects, including hardware/software configuration, documentation, and commissioning activities.
* Participate in capital planning, spending, and tracking within the automation scope.
* Develop and maintain engineering documentation, including User Requirements, Functional Design Specifications, and Network Architectures.
* Develop and execute test scripts (commissioning/qualification protocols) in compliance with GAMP and validation standards.
* Drive automation rollout processes and harmonisation across the network, ensuring consistency and technical compliance.
* Maintain data integrity and ensure systems comply with GxP, Annex 11, and 21 CFR Part 11.
* Stay informed of technology trends (cloud computing, IoT, AI) and contribute to the automation innovation roadmap.
* Collaborate with internal and external stakeholders to align and implement best practices in automation.
Qualifications & Experience:
* Degree in Automation, Robotics, Computer Science, Electrical, Process, or Mechanical Engineering, or equivalent.
* Minimum of 5 years' experience in GMP manufacturing with expertise in automation or operational technology.
* Strong knowledge of automation systems such as Siemens, Omron, Mitsubishi (PLC, HMI, SCADA), iFix, Wonderware, Inmation, and protocols such as OPC, Modbus, Ethernet/IP, Profinet, Profibus.
* Familiarity with GAMP software development lifecycle, ANSI/ISA standards (88, 95, 101, 105, 106), and regulatory requirements (21 CFR Part 11, Annex 11).
* Working knowledge of network architecture technologies, including TCP/IP, routing, switching, and cybersecurity elements such as firewalls and domain integration.
* Excellent analytical, troubleshooting, and documentation skills with the ability to work independently and manage multiple priorities.
* Experience supporting automation within complex, global, or matrix organisations is desirable.
* Knowledge of data analysis tools and emerging technologies (AI, IoT, cloud-based automation) is an advantage.