Validation Specialist – Biotech Downstream Process Equipment
Mentor Technical GroupUnited 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) provides comprehensive technical support and solutions for the FDA-regulated industry. They specialize in life science engineering and technical solutions, serving clients globally in the United States, Puerto Rico, and Boston. This role focuses on validating downstream process equipment, risk assessments, and regulatory compliance.
Requirements
- Develop, review, and execute validation protocols (IQ, OQ, PQ)
- Perform risk assessments, gap analyses, and validation reports for new and existing equipment
- Collaborate with engineering, QA, and operations teams
- Support commissioning and qualification activities for bioprocess systems
- Review and approve validation documentation, SOPs, and change controls
- Identify and implement continuous improvement initiatives in validation processes