Validation Engineering

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, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Professional Summary

Experienced professional in laboratory protocol review, document revision, and validation of laboratory computerized systems (CSV) and SOPs. Skilled in LIMS and Empower, with extensive experience in laboratory instrument performance qualification and method configuration. Knowledgeable in regulatory compliance, data integrity, and project management within pharmaceutical manufacturing environments.

Professional Experience & Skills

Review and revise laboratory protocols and related documents

Provide CSV (Computerized System Validation) and SOP validation services for laboratory equipment

Experienced in LIMS and Empower platforms

Laboratory instrument performance qualification, execution, and method configuration

Familiar with GAMP5 methodology for validations

At least 3 years of experience with PLCs, industrial computers, or laboratory instrumentation systems

Strong understanding of network communication protocols (e.g., TCP/IP)

Proficient in project management tools and Visio

Skilled in writing validation, commissioning, and technical documentation in English using MS Office applications

Bilingual: English and Spanish

Education & Qualifications

BS or higher in Chemistry, Biology, Microbiology, Computer Science, Information Systems, Engineering, or a related discipline

More than 5 years of experience validating laboratory computerized systems in a manufacturing environment

Trained in validation methodologies, technologies, and process control computer systems

Strong knowledge of cGMP, FDA 21 CFR Part 11, and Data Integrity regulations

Knowledgeable in computerized data collection systems and laboratory databases

Background in pharmaceutical product manufacturing

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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