Laboratory Validation Specialist

Flexible & Integrated Technical Services, LLC•Añasco, PR

3d•Onsite

About The Position

This role is for Laboratory Validation Specialist services within the Quality Assurance/Validation area. The ideal candidate will have a Bachelor's Degree in Life Sciences or a related discipline and at least two years of experience in laboratory qualification, validation, and lifecycle management within the Pharmaceutical or Medical Devices industry. Bilingual proficiency in Spanish and English is required, along with strong communication skills. The position operates on an administrative shift, adaptable to business needs.

Requirements

Bachelor's Degree in Life Sciences or related discipline
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)
Experience in Computer System Validation (CSV), including ST and UAT execution.
Experience in Laboratory Equipment Qualification, Laboratory Instrumentation, and Equipment Lifecycle Management.
Experience with Data Integrity (ALCOA+), GMP, GDP, GxP, and 21 CFR Part 11 compliance requirements.
Experience with Change Control, Risk Assesments, and FMEA methodologies.
Experience with LIMS, Empower, and Validation Documentation development, review and execution.

Nice To Haves

Customer service skills
Innovative mindset
Eagerness to innovate
Ability to deliver top-quality results

Responsibilities

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.