CQV Specialist – Upstream Process Equipment

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 has the knowledge and experience to ensure 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: 
+ Develop, review, and execute Commissioning, Qualification, and Validation (CQV) protocols for upstream process equipment (IQ, OQ, PQ).
+ Support equipment design reviews and provide validation input during procurement and installation phases.
+ Perform risk assessments and identify critical quality attributes (CQAs) and critical process parameters (CPPs).
+ Document and report validation results, ...