Senior C&Q Specialist - Pharma, GMP, Bilingual

MENTOR Technical Group Corporation; Manatí (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading technical support firm based in Puerto Rico is seeking a skilled professional to support Commissioning and Qualification (C&Q) activities geared towards pharmaceutical manufacturing. Candidates should have over 5 years of experience in equipment validation and a strong understanding of cGMP regulations. Bilingual candidates fluent in English and Spanish are preferred. This role involves ensuring compliance, managing documentation, and facilitating knowledge transfer within teams to maintain high quality in operations.

Qualifications

• Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.
• Demonstrated experience in C&Q activities.
• More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.
• Excellent skills in writing validation, commissioning, and technical documentation in English.

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.
• Manage change controls and deviations related to plants and equipment.

Skills

Pharmaceutical product manufacturing

Commissioning and Qualification (C&Q)

Good Manufacturing Practices (cGMP)

Technical documentation writing

Bilingual in English and Spanish

Tools

MS Office applications

Digital validation solutions

Job description

A leading technical support firm based in Puerto Rico is seeking a skilled professional to support Commissioning and Qualification (C&Q) activities geared towards pharmaceutical manufacturing. Candidates should have over 5 years of experience in equipment validation and a strong understanding of cGMP regulations. Bilingual candidates fluent in English and Spanish are preferred. This role involves ensuring compliance, managing documentation, and facilitating knowledge transfer within teams to maintain high quality in operations.