GMP C&Q Specialist – Commissioning & Qualification Expert

Mentor Technical Group; Juncos (PR); On-site; USD 76,000 - 98,000; Full time

Job summary

Mentor Technical Group seeks an engineer experienced in commissioning and qualification within GMP manufacturing to support FDA-regulated projects in Puerto Rico or the Boston area. You will collaborate with C&Q Engineers to develop procedures, write protocols, and execute qualification activities for plants and equipment.

The role emphasizes regulatory compliance, quality standards, and effective documentation, with opportunities to coordinate with external consultants and internal teams,

Qualifications

• Bachelor's or Master's in Chemical Engineering, Pharmaceutical Technology, or related field.
• At least 2 years' GMP manufacturing experience.
• Proficiency in English; other languages are a plus.
• Strong regulatory knowledge and quality standards.
• Excellent analytical, problem-solving, and communication abilities.
• Ability to collaborate in a team environment.

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 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

Skills

GMP experience

English proficiency

Analytical skills

Teamwork

Education

Bachelor's or Master's in Chemical Engineering, Pharmaceutical Technology, or related field

Job description

Mentor Technical Group seeks an engineer experienced in commissioning and qualification within GMP manufacturing to support FDA-regulated projects in Puerto Rico or the Boston area. You will collaborate with C&Q Engineers to develop procedures, write protocols, and execute qualification activities for plants and equipment.

The role emphasizes regulatory compliance, quality standards, and effective documentation, with opportunities to coordinate with external consultants and internal teams,