Sr. C&Q 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 (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.

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.

Qualifications / Requirements / Knowledge / Skills

• Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.
• Demonstrated experience in Commissioning and Qualification (C&Q) activities.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
• More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities.
• 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 Spani

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.