Quality Industrialization Engineer (M/F)

Your tasks

Job Description: Project Quality and Validation Engineer (M/F) - Temporary - Offranville (76) Within the Project Quality and Validation department, you will work on various industrial projects and ensure the monitoring of validation activities, in connection with clients and internal teams.

Your main missions

• Analyze customer needs and ensure the interface with them during validation phases
• Develop validation plans, protocols, and reports in French and/or English
• Implement the necessary documents and tools for production: control ranges, plans, specifications, and instructions
• Open and monitor change controls and verify the compliance of validation files
• Monitor sterilization programs, bioburden, analyses, and associated reports
• Analyze data from Excel, Minitab, and monitoring tools
• Issue test certificates and present validation files during client audits
• Participate in internal and external audits as well as the validation of IT systems
• Collaborate with the industrialization, metrology, project management, and production departments
• Participate in project launches, their transfer to production, and continuous improvement processes.

You will ensure compliance with Quality, Safety, and Environment requirements, particularly GMP and safety instructions, as well as maintaining an environment compliant with 5S principles.

Requirements

• Master's degree (Bac +4/5), ideally in a technical, process, or QHSE field
• First experience in project quality, validation, or a regulated industrial environment
• Fluent English in both written and spoken forms, with ease in internal and external exchanges
• Rigor, organization, autonomy, and good analytical and synthesis skills
• Taste for project-based work and the ability to collaborate with different departments
• Knowledge of ISO 9001, ISO 13485, and ISO 15378 standards is appreciated
• Knowledge of ETO/Gamma sterilization, validation plans, and associated frameworks is appreciated
• Proficiency in IT tools, notably Excel, SAP, and data analysis tools; Minitab is appreciated
• Knowledge of Good Manufacturing Practices (GMP) desired.

What we offer

• Remuneration according to profile
• Other job conditions will be specified during your discussion with Synergie Dieppe.

Other

A transversal position to evolve in a demanding industrial environment, at the heart of quality, validation, regulation, and project management challenges.