Labeling Project Engineer: Validation, Compliance & Leadership

FITS LLC; Añasco (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Lead Labeling Engineer to drive labeling update projects with strict adherence to regulatory and quality requirements. You will manage change controls end-to-end, collaborate with Quality, Regulatory Affairs, Operations, and IT, and develop validation documentation.

The role requires a Bachelor's in Engineering with 5+ years in validation or labeling within regulated manufacturing.

Qualifications

• Bachelor's Degree in Engineering and at least 5 years of experience in validation, labeling, quality, manufacturing, or other regulated environments.
• Bilingual (Spanish and English).
• Shift: Administrative and per business needs.

Responsibilities

• Lead and execute labeling update projects with timely implementation and regulatory compliance.
• Manage labeling-related change controls from initiation through closure, including planning, documentation updates, verification, stakeholder communication, and effectiveness checks.
• Coordinate cross-functional activities with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Product Development, Engineering, and IT teams.
• Author, review, and execute validation documentation, including plans, protocols, reports, risk assessments, and impact analyses.
• Develop and execute IQ/OQ/PQ activities for labeling equipment, printers, software, and related processes.
• Support qualification and implementation of new label materials, printers, barcode systems, vision systems, and labeling software.
• Investigate and resolve issues during labeling updates, validation activities, or implementation efforts.
• Assess existing labeling processes, identify risks and compliance gaps, and recommend corrective actions.
• Develop, maintain, and monitor project schedules using Microsoft Project with regular status updates.
• Drive continuous improvement in labeling processes, project execution, and data integrity.

Skills

Bilingual (Spanish & English)

Lead labeling projects

Education

Bachelor's Degree in Engineering

Tools

Microsoft Project

PLM/ERP systems

Job description

FITS LLC in Puerto Rico seeks a Lead Labeling Engineer to drive labeling update projects with strict adherence to regulatory and quality requirements. You will manage change controls end-to-end, collaborate with Quality, Regulatory Affairs, Operations, and IT, and develop validation documentation.

The role requires a Bachelor's in Engineering with 5+ years in validation or labeling within regulated manufacturing.