Senior Process Engineer (GMP/CPV) - Process Optimization

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

CIS International LLC in Juncos, PR is seeking a senior engineer to characterize and optimize processes, troubleshoot operations, and lead major system modifications across manufacturing, pilot plants, and capital projects. You will develop and implement engineering solutions, supervise a small team, and coordinate with multiple departments to meet quality, schedule, and budget constraints.

The role emphasizes GMP compliance, data analysis, CPV/Change Control, and continuous improvement, with an

Qualifications

• Bachelor’s degree in Engineering preferred, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
• Knowledge of manufacturing processes, equipment, devices, packaging, and/or process operations is considered a strong plus.
• Fully bilingual in English and Spanish.
• Experience with CPV, Change Control, and GMP documentation is advantageous.

Responsibilities

• Independently provides and/or directs characterization of process optimization strategies and troubleshooting of operational issues.
• Develops, organizes, analyzes and presents interpretation of results for engineering projects of significant scope and complexity.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on project basis.
• Coordinate work with consultants and engineering firms on standard design documents.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

Skills

GxP GMP

Process optimization

Data analysis

Project leadership

Bi-lingual EN/ES

Education

Master's degree in Engineering

Bachelor's degree in Engineering

GxP/GMP environment experience

Spanish bilingual

Tools

DME/PLM

Power BI

SQL

Smartsheet

Job description

CIS International LLC in Juncos, PR is seeking a senior engineer to characterize and optimize processes, troubleshoot operations, and lead major system modifications across manufacturing, pilot plants, and capital projects. You will develop and implement engineering solutions, supervise a small team, and coordinate with multiple departments to meet quality, schedule, and budget constraints.

The role emphasizes GMP compliance, data analysis, CPV/Change Control, and continuous improvement, with an