Equipment Validation Specialist
Core
Execute qualification activities for site equipment to ensure compliance with guidelines and GMP, supporting the production of safe pharmaceuticals and medical solutions.
Role type
Equipment Validation Specialist (Pharmaceutical)
Builds
Qualified pharmaceutical manufacturing systems and equipment
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification protocols (IQ-OQ-PQ), GMP compliance, technical documentation analysis, external consultant management, regulatory reporting, project coordination
Preferred skills
Knowledge of pharmaceutical machines/systems, Microsoft Office proficiency, Documentum and Trackwise systems
Responsibilities
Perform analysis and evaluation of technical documentation for system qualification, Issue qualification protocols (IQ-OQ-PQ), Lead external consultants for system/equipment qualification, Carry out analysis of qualification activities and issue reports, Support Quality Department in preparing Customer Audits and Regulatory Inspections, Collaborate with Site Departments to achieve project goals, Participate in calls/meetings with customers/clients regarding equipment qualification
Seniority
Mid-level, hands-on IC
