Equipment Validation Specialist

Equipment Validation Specialist role at Thermo Fisher Scientific's Ferentino facility, responsible for executing and overseeing qualification activities for site equipment in compliance with GMP standards. The position involves developing protocols, managing external consultants, and preparing documentation for regulatory inspections.

Responsibilities

• Execute qualification activities and ensure compliance with GMP guidelines and company standards
• Develop and issue IQ-OQ-PQ protocols based on technical documentation analysis
• Oversee external consultant activities to ensure proper equipment qualification execution
• Generate qualification reports and support regulatory inspection and customer audit preparation
• Coordinate with site departments and participate in customer calls regarding equipment qualification topics

Requirements

• Technical or scientific degree in engineering, chemistry, pharmacy, or biomedical field
• Minimum 2 years equipment qualification department experience
• Pharmaceutical industry experience
• Knowledge of pharmaceutical machinery and systems
• Fluent English proficiency
• Proficiency in Microsoft Office, Documentum, and Trackwise systems
• Strong problem-solving and teamwork capabilities