Bilingual Validation Engineer — Utilities & GMP

FITS LLC; Ponce (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation Engineer to develop, execute, and maintain validation protocols for critical utility systems in manufacturing environments. You will perform IQ, OQ, PQ activities on compressors, chillers, AHUs/EFs, and generators, ensuring compliance with GMP documentation and change controls.

The role requires a bachelor's degree in engineering and 3–5 years of validated industry experience, plus bilingual English/Spanish.

Qualifications

• Bachelor’s Degree in Engineering or related field; 3–5 years exposure to validation activities in regulated industry.
• Bilingual: English and Spanish.
• Shift: Administrative and according to business needs.
• Experience in developing, executing, and reviewing validation protocols and documentation.
• Hands-on validation experience with utility systems (compressors, chillers, AHUs/EFs, generators).
• Supporting equipment qualification activities: IQ, OQ, PQ; Change Controls, SOPs, deviations, GMP documentation.

Responsibilities

• Develop, execute, review, and maintain validation protocols and documentation for utility systems and associated equipment.
• Perform qualification activities for compressors, chillers, AHUs/EFs, generators, and related manufacturing utilities.
• Execute and support IQ, OQ, and PQ activities, ensuring systems operate within specifications.
• Evaluate utility systems to identify validation gaps and qualification needs.
• Support Change Controls and assess validation requirements for equipment modifications.
• Develop and review SOPs, validation reports, and GMP documentation.
• Support investigations and corrective actions related to validated utility systems.
• Collaborate with Engineering, Quality, and Manufacturing teams to support validation activities.

Skills

Validation protocols

Documentation

IQ/OQ/PQ

Bilingual English/Spanish

Regulated industry

Education

Bachelor's Degree in Engineering or related field

Tools

IQ

OQ

PQ

Job description

FITS LLC in Puerto Rico seeks a Validation Engineer to develop, execute, and maintain validation protocols for critical utility systems in manufacturing environments. You will perform IQ, OQ, PQ activities on compressors, chillers, AHUs/EFs, and generators, ensuring compliance with GMP documentation and change controls.

The role requires a bachelor's degree in engineering and 3–5 years of validated industry experience, plus bilingual English/Spanish.