Industrialization Engineer

Descrizione del lavoro:

The Industrialization Engineer plays a central role in ensuring robust, compliant, and efficient manufacturing processes within a regulated environment. The role drives quality improvement initiatives through CAPA management, process validation, risk analysis, and the implementation of changes, while supporting cross-functional teams in maintaining compliance and operational excellence. Key responsibilities: Facilitate change control, implementation, and continuous improvement initiatives. Plan and execute industrialization activities, including process validation and qualification. Conduct process risk assessments and support risk mitigation activities. Lead CAPA and nonconformance investigations, including root cause analysis. Support compliance with Quality Management System (QMS) and regulatory requirements. Collaborate with Manufacturing, Quality, Supply Chain, and Engineering teams to improve process

Requisiti del candidato:

You hold a degree in Engineering or a related technical discipline, preferably in Mechanical, Electrical, or Mechatronics Engineering. You have a strong understanding of manufacturing processes and solid experience with Quality Management Systems (QMS), CAPA, nonconformance handling, and change management. Experience in a regulated industry, such as Medical Devices, IVD, or Pharmaceuticals, is preferred. Knowledge of validation, process qualification, and risk management methodologies would be an advantage. You are structured and analytical, with strong problem-solving skills, a quality-focused approach, and a continuous improvement mindset. You have strong communication and facilitation skills, enabling you to drive implementation and build alignment across functions. You are fluent in English