Laboratory Validation Specialist

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

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!

Are you the next piece?