As part of a strategically significant greenfield initiative, a state-of-the-art manufacturing facility is being established near Lleida, Spain. The objective is to build a highly automated plant that integrates advanced technologies across all production-relevant and supporting processes. The facility will focus on the production of medical consumables for dialysis treatment—specifically acid concentrates and bicarbonate cartridges.
The new site will be designed and implemented under strict regulatory requirements. This includes compliance with GMP guidelines and international standards such as ISO 13485 (quality management systems for medical devices) and ISO 14001 (environmental management systems).
This project offers a unique opportunity to shape a facility from the ground up from the conceptual phase through the selection and management of external partners to commissioning and certification. It is an interdisciplinary endeavour with high visibility within the organization and will be executed in close collaboration with departments such as engineering, quality, logistics, IT, and regulatory affairs, amongst others, and external suppliers.
Location: Lleida (Spain)
Reporting Line: Director of Manufacturing Operations
Start: Immediately / by arrangement
Your Responsibilities :
– Overall responsibility for initiating, planning, executing, and controlling, the implemention of a new production site in the medical devices industry
– Leading multidisciplinary project teams (engineering, logistics, quality, IT,…)
– Creating and monitoring project plans, budgets, and milestones, aligned with the needs of the project.
– Coordinating with authorities and managing approval processes
– Selecting and managing external partners (planners, construction companies, suppliers)
– Ensuring compliance with safety, environmental, and quality standards
– Reporting to the steering committee and working closely with management
Profile :
– Degree in process engineering, mechanical engineering, chemical engineering, or a related field
– Experience in project management of industrial plants with a green field approach
– Knowledge of GMP, ATEX, ISO 13485 is an advantage
– Strong leadership and communication skills
– Willingness to travel within Europe
– Strong written and verbal communication skills in both Spanish and English are essential
– Formal training in project management is an advantage