Validation & Qualification Manager
Core
Leading validation and qualification activities for sterile veterinary vaccine manufacturing, ensuring GMP compliance for biological and immunological products.
Role type
Senior Validation & Qualification Manager
Builds
Sterile veterinary vaccines via bioprocessing (upstream fermentation/cell culture and downstream aseptic filling)
Domain
Veterinary biopharmaceuticals / Biological process validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation Master Plan development, bioprocessing validation, aseptic processing validation, cleaning validation, environmental monitoring, CAPA management, change control, deviation investigation, tech transfer coordination, team leadership, risk-based thinking
Preferred skills
Knowledge of Eudralex Annexes 1, 5, 11, 15, VICH GLs, Italian language
Technologies
Eudralex, VICH GLs
Responsibilities
Develop and execute Validation Master Plan and Cleaning Validation Master Plan; Lead validation across upstream and downstream bioprocessing operations; Act as Local Management System Owner for Cleaning Validation, Process Validation, Environmental Monitoring, and Leva implementation; Manage and mentor validation professionals; Ensure timely closure of CAPAs, change controls, and deviation investigations; Collaborate with Tech Transfer teams during scale-up
Seniority
Senior, hands-on IC with team leadership