Sr. CSV Specialist/ Lab Equipment Qualification

About the Position

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. We are currently seeking a Sr. CSV Specialist/ Lab Equipment Qualification to join our team in Carolina, Puerto Rico.

Responsibilities

• 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.

Requirements

• 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.

We Offer

• Full Time position in Carolina, Puerto Rico.
• Competitive compensation package.
• Opportunity to work with a leading company in life science engineering and technical solutions.

About the Company

Mentor Technical Group (MTG) 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.

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.