GMP Engineer – Pharma/MedTech, DOE & CAPA Expert

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc. seeks an Engineer for the Juncos, PR area to support GMP-compliant manufacturing activities. The role emphasizes accurate technical reporting, CAPA handling, and cross-functional problem solving in a production setting.

The ideal candidate holds an engineering degree with 2 years of experience and is fluent in Spanish and English, ready to work first or second shift and extend hours as needed to meet project deadlines.

Qualifications

• Experience in GMP-regulated environments (pharma, medical devices or biotech).
• Proficiency in technical report writing.
• Bilingual in Spanish and English (verbal and written).
• Familiarity with packaging equipment, process characterization, validation, monitoring and optimization.
• Strong problem-solving skills with root-cause investigations.
• CAPA (Corrective and Preventive Actions) management experience.
• Proficiency in statistics and DOE methodologies.
• Apply engineering principles to solve production issues.
• Willingness to support non-standard shifts (nights, weekends, holidays).

Skills

GMP experience

Technical report writing

Bilingual Spanish/English

Packaging equipment familiarity

CAPA management

Statistics & DOE

Root cause investigations

Production engineering

Engineering principles application

Education

Engineering degree (Bachelor's or Master's)

Job description

Integrated Services For Productivity & Validation, Inc. seeks an Engineer for the Juncos, PR area to support GMP-compliant manufacturing activities. The role emphasizes accurate technical reporting, CAPA handling, and cross-functional problem solving in a production setting.

The ideal candidate holds an engineering degree with 2 years of experience and is fluent in Spanish and English, ready to work first or second shift and extend hours as needed to meet project deadlines.