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
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