Laboratory Validation Specialist

FITS, LLC; Añasco (PR); On-site; USD 52,000 - 70,000; Full time

Job summary

FITS, LLC is seeking a Laboratory Validation Specialist to support qualification, validation, and lifecycle management for laboratory equipment and computerized systems.

You will execute validation deliverables, including protocols, test scripts, and reports, while ensuring traceability and regulatory compliance.

Qualifications

• Bachelor's degree in Life Sciences or related field with 2+ years in qualification, validation and lifecycle management.
• Bilingual in Spanish and English with strong communication.
• Experience with CSV, ST, UAT and validated documentation.
• Knowledge of Data Integrity (ALCOA+), GMP/GDP/GxP and 21 CFR Part 11.
• Experience with Change Control, Risk Assessments, and FMEA.
• Familiar with LIMS and Empower; validation documentation development, review and execution.

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 docs.
• Support CSV activities in line with internal procedures and regulations.
• Coordinate and execute System Testing (ST) and User Acceptance Testing (UAT).
• Support qualification activities for laboratory instruments and software apps.
• Maintain validation documentation in audit-ready state and ensure GMP/GDP/GxP and 21 CFR Part 11 compliance.
• Participate in risk assessments using FMEA and other tools.
• Support change control and assess validation impact for system/equipment modifications.
• Ensure Data Integrity principles throughout laboratory processes.
• Collaborate with Quality, Lab Ops, IT, Validation, and Engineering teams on projects.
• Assist investigations, CAPAs, and continuous-improvement in validated systems.
• Support regulatory inspections and internal audits as required.

Skills

Bilingual Spanish & English

CSV/ST/UAT testing

Data Integrity ALCOA+ and 21 CFR Part

Change Control & Risk Assessment (FMEA

Team collaboration with QA/Validation

Education

Bachelor's Degree in Life Sciences or related discipline

Tools

LIMS

Empower

Job description

For Laboratory Validation Specialist services in the Quality Assurance/Validation area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree inLife Sciences or related disciplineand at least two (2) years of previous exposure to laboratory qualification, validation, and lifecycle management activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • Computer System Validation (CSV), including ST and UAT execution.
  • Laboratory Equipment Qualification, Laboratory Instrumentation, and Equipment Lifecycle Management.
  • Data Integrity (ALCOA+), GMP, GDP, GxP, and 21 CFR Part 11 compliance requirements.
  • Change Control, Risk Assesments, and FMEA methodologies.
  • LIMS, Empower, and Validation Documentation development, review and execution.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

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

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!