Senior C&Q Lead, Pharma Facilities & Utilities

Mentor Technical Group; Vega Baja (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Mentor Technical Group is seeking an experienced professional to lead Commissioning and Qualification (C&Q) activities for pharmaceutical facilities, with emphasis on sterile packaging operations. The role requires extensive experience in C&Q, cGMP compliance, and documentation in English and Spanish.

You will develop and review C&Q procedures, author protocols, and coordinate with internal teams and external consultants to ensure timely delivery, while managing change controls and deviations to

Qualifications

• 5+ years in Equipment and Computer System Validation within pharmaceutical facilities.
• Experience with Commissioning and Qualification (C&Q) activities.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements.
• Experience with digital validation solutions (e.g., ALM or equivalent systems).
• Excellent skills in writing validation, commissioning, and technical documentation in English.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint, etc.).
• Bilingual proficiency in English and Spanish.

Responsibilities

• Support Commissioning and Qualification (C&Q) activities for plants and equipment.
• Develop, review, and maintain commissioning and qualification procedures and documentation.
• Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and laboratory equipment.
• Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.
• 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

C&Q activities

cGMP knowledge

Documentation drafting

Root cause analysis

English writing

Microsoft Office

English-Spanish bilingual

Tools

ALM or equivalent systems

Job description

Mentor Technical Group is seeking an experienced professional to lead Commissioning and Qualification (C&Q) activities for pharmaceutical facilities, with emphasis on sterile packaging operations. The role requires extensive experience in C&Q, cGMP compliance, and documentation in English and Spanish.

You will develop and review C&Q procedures, author protocols, and coordinate with internal teams and external consultants to ensure timely delivery, while managing change controls and deviations to