Validation Engineer – Pharma/Medical Devices (GMP & FDA)

FITS, LLC; Añasco (PR); On-site; USD 50,000 - 75,000; Full time

Job summary

FITS, LLC is seeking a Validation professional to support engineering and manufacturing validation activities in Puerto Rico. The candidate should have a Bachelor’s in Engineering and exposure to pharmaceutical or medical device validation projects, with bilingual Spanish/English communication.

The role involves writing and executing validation protocols, ensuring FDA-aligned documentation, and contributing to process improvements while supporting day-to-day operations in a dynamic,

Qualifications

• Bachelor's Degree in Engineering with exposure to validation activities in Pharma or Medical Devices.
• Bilingual in Spanish and English with good communication.
• Experience in SOP Development, Validation Documentation, GMP & GDP.

Responsibilities

• Write, execute and maintain validation protocols.
• Ensure timely, thorough execution of protocols meeting FDA requirements.
• Integrate protocols into manufacturing processes and maintain documentation in the quality system.
• Investigate product and batch deviations related to validation sampling and testing; document investigations.
• Develop and implement process strategies, optimize processes, and maintain process documents.
• Support day-to-day process operations.

Education

Bachelor's Degree in Engineering

Job description

FITS, LLC is seeking a Validation professional to support engineering and manufacturing validation activities in Puerto Rico. The candidate should have a Bachelor’s in Engineering and exposure to pharmaceutical or medical device validation projects, with bilingual Spanish/English communication.

The role involves writing and executing validation protocols, ensuring FDA-aligned documentation, and contributing to process improvements while supporting day-to-day operations in a dynamic,