Job Description:
We are seeking an Automation Engineer to join our team and ensure the availability, compliance, and performance of site automation systems while supporting continuous improvement and global automation initiatives.
Main Responsibilities:
* Monitor performance and ensure maximum uptime for automation systems as system administrator.
* 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.
Requirements & Qualifications:
* 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, 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.