Sr. CSV Specialist/ Lab Equipment Qualification

Mentor Technical Group • North, PR

11d

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. 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.

Requirements

• Experienced in LIMS and Empower platforms.
• 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.
• Bilingual: English and Spanish.
• 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.

Responsibilities

• Review and revise laboratory protocols and related documents.
• Provide CSV (Computerized System Validation) and SOP validation services for laboratory equipment.
• Laboratory instrument performance qualification, execution, and method configuration.
• Writing validation, commissioning, and technical documentation in English using MS Office applications.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level