Technical Lead (Industrial) 4 nyitott pozíció

Ceva-Sante Animale is seeking Four full-time candidates for the role of Industrialization Operations Engineer (Greenfield Site) . The role will support/lead the start-up activities of our newest green-field investment of the Phylaxia campus in Monor. The Phylaxia Campus is one of the flagship sites of the Ceva Animal Health Group. The Industrialization Department focuses on the development, optimization and scale-up of manufacturing technologies, as well as the efficient management of technology transfers between various production sites. The role focuses on the transfer, and validation of manufacturing technologies, particularly in antigen production and vaccine formulation filling. The Biopharmaceutical Operation Start-up Specialist plays a key role in the transition from construction to cGMP manufacturing. The role sill bridge between the "build" phase and the "operate" phase ensuring that during final process validation all equipment, utilities, and systems meet applicable regulatory standards (NEBIH/EMA) and are ready for routine cGMP manufacturing. KEY RESPONSIBILITIES Support validation processes and preparation/review of the required documentation (e.g., SOPs, validation plans/ protocols/ reports) Oversee the execution of Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Organize and lead execution of qualification activities within the production areas Participating in the development of new production areas, including technical specifications and investment preparation Onboarding: support and monitoring of the integration process for new employees Team Management: Managing a team of at least 5 people, handling conflicts, providing feedback, and managing daily distribution of tasks. Manage the hand-over from the engineering team (CAPEX) to the manufacturing team, ensuring SOPs (Standard Operating Procedures) are drafted and operators are trained. Support the process of developing digital solutions, such as electronic Batch Record. Ensure all documentation—including User Requirement Specifications (URS), Traceability Matrices, and Summary Reports—is "Inspection Ready" and adheres to ALCOA+ principles.