Bilingual Manufacturing Validation Engineer (2nd Shift)

fitspr; Dorado (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS is seeking a qualified engineer to support validation and qualification of manufacturing equipment and processes on 2nd shift (12:00pm-9:00pm) in Puerto Rico. The role requires a Bachelor's degree in engineering and 2–3+ years in a manufacturing setting.

Bilingual in English and Spanish is required. Responsibilities include GMP documentation, protocol execution, and collaboration with Quality and Engineering teams to drive continuous improvement.

Qualifications

• Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering or related field.
• 2+ years in manufacturing with validation protocol execution.
• Bilingual (English & Spanish).

Responsibilities

• Support creation, execution, and maintenance of qualification and validation activities for manufacturing processes and systems.
• Generate and maintain manufacturing and system documentation for process changes and equipment implementation.
• Assist in validation/qualification protocols and associated reports.
• Provide ongoing support for daily manufacturing operations and process performance monitoring.
• Support quality system processes and manufacturing compliance requirements.
• Monitor manufacturing metrics and identify opportunities for improvement.
• Coordinate qualification, validation, and protocol execution across Manufacturing, Quality and Engineering teams.
• Prepare and maintain qualification protocols, validation reports, risk assessments, and other compliance docs.

Skills

Bilingual English/Spanish

Validation protocols

Quality system understanding

Education

Bachelor's in Engineering or related field

Job description

FITS is seeking a qualified engineer to support validation and qualification of manufacturing equipment and processes on 2nd shift (12:00pm-9:00pm) in Puerto Rico. The role requires a Bachelor's degree in engineering and 2–3+ years in a manufacturing setting.

Bilingual in English and Spanish is required. Responsibilities include GMP documentation, protocol execution, and collaboration with Quality and Engineering teams to drive continuous improvement.