GMP Process Engineer – Life Sciences (DOE & CAPA)

Inteldot; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Inteldot seeks a qualified engineer to optimize manufacturing processes in a GMP-regulated setting. Responsibilities include solving technical issues, conducting root cause analyses, and supporting CAPA and DOE activities across packaging and production lines.

The role emphasizes collaboration with QA, validation, and maintenance teams, along with training and equipment qualifications. Strong English/Spanish communication is required.

Qualifications

• Experience in GMP-regulated pharma/medical device/biotech environments.
• Proficiency in technical report writing.
• Bilingual in Spanish and English (verbal and written).
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
• Strong problem-solving skills and experience with root cause investigations.
• Expertise in CAPA identification and management.
• Proficiency in statistical analysis and DOE methodologies.
• Ability to apply engineering principles to solve production issues.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Act as a technical expert during troubleshooting and cross-functional discussions.
• Frequently engage in daily operations to meet schedules and resolve complex issues.
• Routinely supervise manufacturing processes for KPIs and mentor troubleshooting.
• Collaborate with manufacturing, maintenance, process development, QA, validation to define requirements for modifications.
• Support deviations, equipment qualification, process validation, procedures, training, and new product introductions.
• Apply engineering, scientific, and analytical skills to support manufacturing operations.
• Organize, analyze, and present results for operational issues or projects of moderate scope and complexity.
• Support 7/24 non-standard shift operation including extended hours and weekends as needed.

Skills

Report writing

Spanish/English bilingual

Packaging equipment

Root cause analysis

CAPA management

DOE methodologies

Statistical analysis

Engineering problem solving

Education

Bachelor's in engineering + 2 years of experience

Job description

Inteldot seeks a qualified engineer to optimize manufacturing processes in a GMP-regulated setting. Responsibilities include solving technical issues, conducting root cause analyses, and supporting CAPA and DOE activities across packaging and production lines.

The role emphasizes collaboration with QA, validation, and maintenance teams, along with training and equipment qualifications. Strong English/Spanish communication is required.