Senior Validation Engineer (CQV) - STAFTONIC LLC : Job Details

Key Responsibilities: Lead CQV activities for equipment, utilities, facilities, and processes Author and execute validation protocols (IQ/OQ/PQ, VMP, URS, etc.) Manage electronic validation systems (e.g., ValGenesis, Kneat) Coordinate with internal teams and external vendors Ensure compliance with cGMP and regulatory standards Support audits, CAPAs, and continuous improvement projects Oversee transition to new validation management platform Requirements: Bachelor's in Engineering, Science, or related field 10–12+ years in CQV/validation in biotech or aseptic manufacturing Expertise in cGMP, FDA/EMA regulations Experience with electronic validation tools (ValGenesis, Kneat, Veeva) Strong project management and communication skills