Validation Engineer – Pharma & Medical Devices

FITS LLC; Añasco (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation professional to join our engineering and manufacturing services team. You will develop, write, and maintain validation protocols and ensure FDA-compliant execution across manufacturing operations.

The role requires a Bachelor's in Engineering, bilingual English/Spanish, and experience with SOP development, validation documentation, GMP and GDP, with flexibility to adapt to business needs.

Qualifications

• Bachelor’s degree in engineering with exposure to validation activities in pharma or medical devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative and flexible per business needs.
• Experience in SOP development, validation documentation, GMP & GDP.

Responsibilities

• Write, execute and maintain validation protocols.
• Ensure timely, thorough and FDA-compliant execution of protocols.
• Integrate new and existing protocols into manufacturing processes.
• Ensure documentation is thorough and entered into the quality system.
• Investigate product/batch deviations related to validation testing.
• Document investigations and communicate findings to minimize recurrence.
• Develop and implement process strategies and maintain process documents.
• Support day-to-day process operations.

Skills

Bilingual Spanish & English

SOP Development

Validation Documentation

GMP & GDP

Shift flexibility

Exposure to validation activities

Education

Bachelor's Degree in Engineering

Job description

FITS LLC in Puerto Rico seeks a Validation professional to join our engineering and manufacturing services team. You will develop, write, and maintain validation protocols and ensure FDA-compliant execution across manufacturing operations.

The role requires a Bachelor's in Engineering, bilingual English/Spanish, and experience with SOP development, validation documentation, GMP and GDP, with flexibility to adapt to business needs.