QA Validation Engineer
Core
Execute validation activities for facilities, utilities, equipment, systems, processes, cleaning, and laboratory instruments to maintain a validated state in compliance with cGMP and regulations.
Role type
Mid-level IC validation engineer
Builds
Validated state of manufacturing systems and processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Validation protocols execution, cGMP compliance, documentation, risk assessment, investigation support, cross-functional coordination
Preferred skills
RAM, Maximo, KNEAT, TrackWise, Veeva Vault, Temperature mapping devices
Technologies
RAM, Maximo, KNEAT, TrackWise, Veeva Vault, Kaye, Ellab, Temptales
Responsibilities
Execute assigned validation tasks for equipment, utilities, and processes; Support investigations of validation discrepancies; Draft and revise validation documents (protocols, reports, risk assessments); Coordinate routine qualifications and requalifications; Participate in new installations or system changes to ensure cGMP compliance.
Seniority
Mid-level, hands-on IC
