Lead CSV Specialist — Lab Equipment Validation & Compliance

MENTOR Technical Group Corporation; Boston (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

MENTOR Technical Group Corporation in Boston is seeking an experienced professional skilled in laboratory protocol review, document revision, and validation of computerized systems. Applicants should have extensive experience with LIMS, strong regulatory compliance knowledge, and proficiency in project management tools. A BS or higher in a relevant field and over 5 years of validated experience are required. The role may appeal to individuals fluent in English and Spanish. MENTOR promotes an inclusive workplace with equal opportunity employment.

Qualifications

• Experienced in document revision and validation of laboratory computerized systems.
• Strong knowledge of regulatory compliance, data integrity, and project management.
• At least 3 years of experience with PLCs, industrial computers, or laboratory instrumentation systems.

Responsibilities

• Review and revise laboratory protocols and related documents.
• Provide CSV and SOP validation services for laboratory equipment.
• Skilled in writing validation, commissioning, and technical documentation.

Skills

Laboratory protocol review

Computerized System Validation (CSV)

LIMS and Empower expertise

Laboratory instrument performance qualification

Project management tools

Bilingual in English and Spanish

Education

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

More than 5 years of experience validating laboratory computerized systems

Tools

MS Office applications

Visio

Job description

MENTOR Technical Group Corporation in Boston is seeking an experienced professional skilled in laboratory protocol review, document revision, and validation of computerized systems. Applicants should have extensive experience with LIMS, strong regulatory compliance knowledge, and proficiency in project management tools. A BS or higher in a relevant field and over 5 years of validated experience are required. The role may appeal to individuals fluent in English and Spanish. MENTOR promotes an inclusive workplace with equal opportunity employment.