Position Overview
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG ensures compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
+ Review and audit validation, qualification, and verification activities across manufacturing, packaging, utilities, facilities, laboratories, and systems.
+ Participate in defining validation/qualification strategies for product transfers and site product changes, including regulatory impact assessments.
+ Review and approve Operational Qualification (OQ), Performance/Process Qualification (PQ), and Verification activities, along with a...