Bilingual Manufacturing Engineer: Validation & Process

FITS LLC; Dorado, Northern (PR, KY); Hybrid; USD 60,000 - 80,000; Full time

Job summary

FITS LLC in Dorado, Puerto Rico, seeks a qualified engineer to support qualification and validation activities in a manufacturing environment. The role requires a relevant engineering degree, 2-3+ years of experience, and experience generating validation protocols for manufacturing equipment.

You will collaborate across Manufacturing, Quality, and Engineering to ensure GMP compliance, maintain documentation, and support continuous improvement.

Qualifications

• Bachelor's degree in mechanical, electrical, industrial, manufacturing, or biomedical engineering.
• 2-3+ years of experience in a manufacturing environment.
• Experience generating and executing validation protocols for manufacturing equipment.
• Bilingual English and Spanish.

Responsibilities

• Support the creation, execution, and maintenance of qualification and validation activities related to manufacturing processes and systems.
• Generate and maintain manufacturing and system documentation required to support process changes, equipment implementation, and compliance requirements.
• Actively support the execution of validation and qualification protocols and generate supporting reports.
• Provide ongoing support for daily manufacturing operations and process performance monitoring.
• Support activities related to quality system processes and manufacturing compliance requirements.
• Monitor manufacturing metrics and assist in identifying opportunities for improvement.
• Coordinate qualification, validation, and protocol execution activities across Manufacturing, Quality, and Engineering teams.
• Prepare, review, and maintain qualification protocols, validation reports, risk assessments, and other compliance-related documentation.
• Support deviation investigations, CAPA activities, and data integrity initiatives to ensure regulatory compliance.
• Monitor manufacturing yields, process performance trends, and key performance indicators to identify and support continuous improvement opportunities.

Skills

Bilingual (English & Spanish)

Validation protocol development

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering

Job description

FITS LLC in Dorado, Puerto Rico, seeks a qualified engineer to support qualification and validation activities in a manufacturing environment. The role requires a relevant engineering degree, 2-3+ years of experience, and experience generating validation protocols for manufacturing equipment.

You will collaborate across Manufacturing, Quality, and Engineering to ensure GMP compliance, maintain documentation, and support continuous improvement.