Consultant qualification/validation F/H
Core
Consultant ensuring regulatory compliance and qualified status of pharmaceutical equipment, installations, and utilities through qualification projects.
Role type
Senior IC pharmaceutical validation consultant
Builds
Qualified status of production equipment, pharmaceutical utilities (HVAC, water, gas), cleanrooms, and automated systems
Domain
Pharmaceutical industry + Quality Assurance/Validation
Required skills
GMP/BPF compliance knowledge, qualification protocol writing (IQ/OQ/PQ), on-site testing, deviation/CAPA management, risk analysis (FMEA/HACCP), technical reporting
Preferred skills
Process engineering background, field work experience, strong writing skills, autonomy
Technologies
HVAC systems, water systems, gas systems, automated systems, cleanrooms
Responsibilities
Define qualification strategy, write qualification protocols, perform on-site tests, write qualification reports, identify and process deviations, participate in risk analyses, maintain qualified status of equipment, collaborate with production/maintenance/quality teams
Seniority
Mid-level, hands-on IC