System Lead

The System Lead is responsible for the full lifecycle management of critical Operational Technology (OT) systems within a regulated medical manufacturing environment. This role ensures systems are reliable, compliant, and aligned with business and regulatory requirements, while supporting manufacturing operations such as BMS, SCADA, and fumigation control systems.

The preceding job description had been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties and responsibilities required of employees assigned to this job.

• Own and manage the end-to-end lifecycle of assigned computer systems, including
• Planning and requirements definition
• Design and development
• Testing and validation
• Implementation and release
• Technical operation and ongoing maintenance
• Change management and system enhancements
• Ensure compliance with internal IT standards, quality processes, and regulated industry requirements (e.g. GxP)
• Act as the primary system owner accountable for system performance, availability, and compliance
• Maintain and continuously update system architecture documentation throughout the system lifecycle
• Collaborate with engineering, manufacturing, quality, and external vendors to support system improvements and troubleshooting
• Coordinate system-related activities across IT and business teams, ensuring:
  • Appropriate task assignment
  • Clear ownership of deliverables
  • Timely execution of activities

• Education in a scientific discipline; computer science or engineering
• At least 3 years' experience in similar role
• Basic knowledge of regulated environments and industry standards, including
  • 21 CFR Part 11 & EU Annex 11
• Experience working in or supporting Operational Technology environments, ideally within manufacturing
• Strong analytical and problem‑solving skills, with the ability to diagnose and resolve system issues
• Effective communication and coordination skills to work across multidisciplinary teams

• Competitive salary and benefits package
• AFB bonus
• Private health scheme including Private Medical, Dental, Optical and Holiday Travel
• Opportunities to learn and develop: training programs
• Personalized career path within the organization
• Exposure to an international environment as part of a multicultural team spread across Europe

Here at the Stefanini Group, we value plurality and equity, regardless of race, sexual orientation, disability, age, ancestry, religion, gender, and nationality. We understand and encourage the importance of being you!