Senior CSV & Lab Equipment Validation Specialist

Mentor Technical Group; Carolina (PR); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading technology solutions firm is seeking an experienced professional specializing in laboratory protocol review and validation of computerized systems. The role emphasizes ensuring compliance with pharmaceutical standards and utilizing expertise in LIMS and Empower. Candidates should have a strong background in project management and validation methodologies. Bilingual proficiency in English and Spanish is preferred. The position is based in Carolina, Puerto Rico, offering an inclusive and equal opportunity work environment.

Qualifications

• At least 3 years of experience with PLCs and laboratory instrumentation systems.
• More than 5 years of experience validating laboratory computerized systems.
• Strong understanding of regulatory compliance (cGMP, FDA regulations).

Responsibilities

• Review and revise laboratory protocols and related documents.
• Provide CSV and SOP validation services for laboratory equipment.
• Conduct laboratory instrument performance qualification and method configuration.

Skills

Laboratory protocol review

Computerized System Validation (CSV)

SOP validation

LIMS expertise

Empower proficiency

Project management

Bilingual (English and Spanish)

Education

BS or higher in relevant discipline

Tools

MS Office applications

Visio

Job description

A leading technology solutions firm is seeking an experienced professional specializing in laboratory protocol review and validation of computerized systems. The role emphasizes ensuring compliance with pharmaceutical standards and utilizing expertise in LIMS and Empower. Candidates should have a strong background in project management and validation methodologies. Bilingual proficiency in English and Spanish is preferred. The position is based in Carolina, Puerto Rico, offering an inclusive and equal opportunity work environment.