Commissioning & Qualification

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: 

• Collaborate with C&Q Engineers to develop and maintain commissioning and qualification procedures and documents.
• Write, review, and approve C&Q protocols and reports for various systems (e.g., HVAC, utilities, production equipment, lab equipment).
• Execute commissioning and qualification activities for plants and equipment.
• Coordinate with external consultants and internal resources to ensure timely document generation and execution.
• Manage change controls and deviations related to plants and equipment.
• Support maintenance and calibration functions to improve compliance and quality.
• Provide expertise in troubleshooting and root cause investigations.
• Facilitate the transfer of technical knowledge across units and sites.

Qualifications Requirements/Knowledge/Education/Skills: 

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
• At least 2 years of experience in GMP manufacturing relevant to the area of expertise.
• Proficiency in English; additional language skills are a plus.
• Strong understanding of regulatory requirements and quality standards.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a team environment.