CQV Specialist – Upstream Process Equipment & Downstream Biotech Process Equipment
Mentor Technical GroupPuerto Rico, United States • Puerto Rico, United States • Boston, Massachusetts, United States
Posted September 5, 2025
Full Time
About the Company
Mentor Technical Group is a minority-owned business specializing in multidisciplinary compliance, technical, and engineering services for life science and highly regulated industries. With a team of skilled professionals and an ISO 9001 certified Quality System, Mentor offers comprehensive solutions that ensure client confidence, operational efficiency, and risk reduction. The company's commitment to innovation, process integrity, and scalable management methods sets them apart as a trusted partner in the industry.
Job Description
Mentor Technical Group (MTG) is seeking a Quality Control/Validation Specialist to support the FDA-regulated industry. MTG provides comprehensive technical support and solutions for process equipment, emphasizing compliance with safety and efficacy guidelines. The role involves qualification, validation, equipment installation, and regulatory documentation. MTG has offices in Caguas, Puerto Rico, and Boston.
Requirements
- Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or related field
- Minimum 3–5 years of experience in commissioning, qualification, and validation of biotech process equipment (both upstream and downstream)
- Strong knowledge of GMP, FDA, cGMP, and international regulatory requirements
- Hands-on experience developing and executing IQ, OQ, and PQ protocols
- Excellent teamwork, communication, and problem-solving skills
- Proficiency in technical documentation software and validation tools