Develop and execute characterization and validation protocols and reports, ensuring compliance with FDA regulations in the life sciences industry.
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
- Development of Characterization and Validation protocols
- Execution of Characterization and Validation protocols
- Develop Characterization and Validation reports
Education & Qualifications:
- Bachelor's degree in engineering and 5 years of Scientific experience or Master's degree and 3 years of Scientific experience (Mechanical Engineering, Industrial Engineering, Chemical Engineering, Electrical Engineering, or Scientist)
- Fully Bilingual (Spanish and English)
- Characterization and Validation experience
- URS, DS, and Equipment Risk Assessments
- Device assembly equipment and packaging equipment validation experience
- Experience in Combination Products or Medical Devices
Top Skills
Characterization
Device Assembly Equipment
Engineering
Fda Regulations
Packaging Equipment
Validation
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