CSV Specialist

Role Description

• 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 lab 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

• 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 other regulatory requirements.
• More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.
• Experience with digital validation solutions (e.g., ALM or equivalent).
• Excellent skills in writing validation, commissioning, and technical documentation in English.
• Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).
• Bilingual: fluent in English and Spanish.

Company 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.