Hybrid (up to 2 days remote work per week after 4 months)
Validation master plan
Process risk assessment
Continued process verification
LFB Biomanufacturing is seeking a Responsable Validation Procédés in Lille or Les Ulis, France. The role involves overseeing the validation and qualification strategy for products, leading a team of 10, and ensuring compliance with regulatory standards in the biomanufacturing processes
Job Summary
Propose the validation/qualification strategy for products and ensure the production of deliverables to guarantee that processes are validated and maintained in a validated state in compliance with GMP.
Define and improve the principle of Continued Process Verification (CPV-stage 3), organize protocols, and coordinate the CPV exercise with sites.
Lead a team of 10 people, pilot their performance, develop collaborators, and ensure recruitment and integration of new team members.
Matching Summary
Match Score: 85
LFB Biomanufacturing is seeking a Responsable Validation Procédés in Lille or Les Ulis, France. The role involves overseeing the validation and qualification strategy for products, leading a team of 10, and ensuring compliance with regulatory standards in the biomanufacturing processes.
Skills & Requirements
Must-have
Validation Master Plan
Process Risk Assessment
Continued Process Verification
CAPA management
Change Control impact assessment
Nice-to-have
Team leadership and development
Communication and change management
Continuous improvement mindset
Key Requirements
Minimum 10 years of operational experience in pharma