Industrialization & Operations Engineer (Greenfield Site)

Ceva-Sante Animale is seeking full-time applicants 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.

• 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.

• We offer an exceptional annual cafeteria equivalent to a 13th month salary
• You are eligible for an annual bonus scheme based on both individual and company performance, equivalent to a minimum of an additional month’s salary
• We prioritize your health with a premium private insurance package
• We support your health with complimentary sports and fitness opportunities
• We provide school starting support to assist your family
• We offer free and secure parking for employees who commute by car
• Regardless of age, all employees are entitled to 25 annual vacation days
• Lunchtime is more enjoyable as it is part of our working hours

 
WHY CEVA-PHYLAXIA?

• Together, our passionate people drive innovative health solutions for all animals, contributing to the future of our diverse
• planet.
• We dedicate our work to protect animal welfare every day
• We offer stable employment in a resilient industry
• Our business has been growing exponentially
• We offer comprehensive training opportunities
• You can join a dynamically growing team of professionals
• We provide great benefits focusing on your commitment and well-being

• Relevant MSc degree (e.g. biochemical engineering, biotechnology, food engineering)
• Relevant cGMP experience
• Minimum of 3 years of professional experience in a related field, with a strong focus on Commissioning and Qualification
• English and Hungarian proficiency, both written and spoken
• Understanding of automated systems and process automation

• Experience in fermentation, formulation
• Experience in batch/recipe control/edit
• Experience in control loop tuning (e.g. PID) and distributed Control System (DCS)
• Hands-on experience with cleanrooms, HVAC, purified water (WFI), Pure Steam (PS)