Validation Engineer - Pharma & Medical Devices, GMP-Driven

FITS LLC; Añasco, Northern (PR, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation professional to support validation protocols and reports across Engineering and Manufacturing. The role emphasizes collaboration with internal teams and external suppliers, ensuring compliance with GMP and GDP standards.

You will contribute to change controls, qualification activities, and implementation readiness, while leveraging statistical tools like Minitab or JMP to analyze data and drive quality outcomes.

Qualifications

• Bachelor's Degree in Engineering and exposure to validation activities in Pharma/Med Devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative & according to business needs.
• Experience with protocol development, execution, investigations and technical documentation.

Responsibilities

• Development and execution support of validation protocols and reports.
• Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
• Qualification and operational readiness activities across systems, processes, and infrastructure.
• Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
• Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
• Technical support for supplier qualification and validation activities.

Skills

Bilingual Spanish/English

Statistical tools

GMP GDP knowledge

Validation protocols

Supplier collaboration

Education

Engineering degree

Tools

Minitab/JMP

Job description

FITS LLC in Puerto Rico seeks a Validation professional to support validation protocols and reports across Engineering and Manufacturing. The role emphasizes collaboration with internal teams and external suppliers, ensuring compliance with GMP and GDP standards.

You will contribute to change controls, qualification activities, and implementation readiness, while leveraging statistical tools like Minitab or JMP to analyze data and drive quality outcomes.