Lab Validation Specialist — CSV & LIMS

FITS LLC; Añasco (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC is looking for a Laboratory Validation Specialist to support qualification, validation, and lifecycle management of laboratory systems and equipment within the Quality Assurance/Validation area.

A Bachelor’s degree in Life Sciences or related field and 2+ years’ experience, CSV/ST/UAT, LIMS/Empower, and ALCOA+ data integrity knowledge are required; bilingual Spanish/English communication is a must.

Qualifications

• Bachelor's degree in Life Sciences or related discipline with 2+ years of qualification/validation exposure.
• Bilingual in Spanish and English with good communication.
• Experience in CSV including ST and UAT execution.
• Experience in Laboratory Equipment Qualification and Lifecycle Management.
• Knowledge of ALCOA+ data integrity, GMP, GDP, GxP, and 21 CFR Part 11 compliance.
• Experience with Change Control, Risk Assessments, and FMEA methodologies.
• Experience with LIMS, Empower, and validation documentation development/review.

Responsibilities

• Support qualification, validation, and lifecycle management for laboratory equipment and computerized systems.
• Execute and review validation deliverables, including protocols, test scripts, reports, and traceability.
• Support CSV activities in compliance with internal procedures and regulatory requirements.
• Coordinate and execute System Testing (ST) and User Acceptance Testing (UAT).
• Support qualification activities for laboratory instruments and software applications.
• Maintain validation documentation in an audit-ready state and ensure GMP/GDP/GxP and 21 CFR Part 11 compliance.
• Participate in risk assessments using FMEA and other risk-management tools.
• Support change control activities and assess validation impact for system modifications.
• Ensure Data Integrity (ALCOA+) throughout system and laboratory processes.
• Collaborate with Quality, Laboratory Operations, IT, Validation, and Engineering teams.
• Assist with investigations, corrective actions, and continuous-improvement initiatives.
• Support regulatory inspections and internal audits as required.

Skills

Bilingual Spanish/English

Computer System Validation (CSV)

Risk Assessments & FMEA

Data Integrity (ALCOA+)

GxP & 21 CFR Part 11 compliance

Education

Bachelor's degree in Life Sciences or related discipline

Tools

LIMS

Empower

Validation Documentation tools

Job description

FITS LLC is looking for a Laboratory Validation Specialist to support qualification, validation, and lifecycle management of laboratory systems and equipment within the Quality Assurance/Validation area.

A Bachelor’s degree in Life Sciences or related field and 2+ years’ experience, CSV/ST/UAT, LIMS/Empower, and ALCOA+ data integrity knowledge are required; bilingual Spanish/English communication is a must.