GMP Process Optimization Engineer

Cis-International-LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Cis-International LLC is seeking an Operations/Process Engineer to characterize process optimization strategies and troubleshoot operational issues in a manufacturing environment in Juncos, PR. You will apply engineering principles to design and implement system modifications, experiments, and capital projects, with a focus on minor projects and clear objectives.

The role involves collaboration with manufacturing, QA, utilities, and process development to support schedules and budgets, including

Qualifications

• Master’s or Bachelor’s degree in Engineering with 2 years of engineering experience.
• Experience working in GMP-regulated environments (pharma/biotech/medical device).
• Proficiency in technical report writing.
• Fluency in English and Spanish (verbal and written).
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
• Strong problem-solving skills and experience with root-cause investigations.
• Experience identifying and managing CAPAs; proficiency in DOE methodologies.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision.
• Work with cross-functional teams to develop system modifications and projects.
• Generate rudimentary project cost estimates and schedules.

Skills

GMP experience

Technical report writing

Bilingual English/Spanish

Root cause investigations

CAPA & DOE

Education

Master’s/Bachelor’s in Engineering

Tools

Packaging equipment

Validation methods

DOE/statistical analysis

Job description

Cis-International LLC is seeking an Operations/Process Engineer to characterize process optimization strategies and troubleshoot operational issues in a manufacturing environment in Juncos, PR. You will apply engineering principles to design and implement system modifications, experiments, and capital projects, with a focus on minor projects and clear objectives.

The role involves collaboration with manufacturing, QA, utilities, and process development to support schedules and budgets, including