Equipment Validation Specialist
Core
Execute qualification activities (IQ-OQ-PQ) for site equipment in compliance with GMP guidelines and regulations.
Role type
Equipment Validation Specialist
Builds
Qualified pharmaceutical manufacturing systems and equipment
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
Equipment qualification protocols, IQ-OQ-PQ reporting, technical documentation analysis, external consultant management, regulatory compliance (EU/US GMP), project coordination
Preferred skills
Knowledge of pharmaceutical machines/systems, problem-solving, Microsoft Office proficiency, Documentum and Trackwise systems
Responsibilities
Analyze technical documentation to define qualification protocols, issue IQ-OQ-PQ protocols and reports, lead external consultants in system qualification, support Quality Department in audits and inspections, collaborate with site departments on projects, participate in customer meetings regarding equipment qualification
Seniority
Mid-level, hands-on IC