GMP Process Engineer: Validation & Optimization Lead

Mirus Consulting Group; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks an Engineer to provide technical support for manufacturing and packaging in a GMP environment. The role emphasizes process optimization, validation activities, equipment support, and regulatory compliance.

You will lead CAPA initiatives, perform root cause investigations, use DOE and statistical methods to drive improvements, prepare documentation, and collaborate with Manufacturing, Quality, Validation, and Operations.

Qualifications

• Master’s degree in Engineering or Bachelor’s with 2 years of engineering experience.
• Experience in GMP-regulated environments within pharma/biotech/medical device.
• Bilingual proficiency in Spanish and English (written and spoken).
• Proficiency in technical report writing.

Responsibilities

• Provide engineering support for manufacturing and packaging operations.
• Support process characterization, validation, monitoring, and optimization activities.
• Troubleshoot technical issues and lead root cause investigations.
• Identify, develop, implement, and monitor CAPAs to address deviations.
• Analyze process data using DOE and statistical tools.
• Prepare and review technical documentation, reports, protocols, and investigations in GMP.
• Collaborate with Manufacturing, Quality, Validation, and Operations to support projects.
• Evaluate equipment and process performance and provide optimization recommendations.
• Ensure engineering activities comply with site procedures and quality standards.
• Support audits, inspections, and special projects.

Skills

Process optimization

Validation activities

Root cause analysis

CAPA management

DOE

Statistical analysis

Technical report writing

GMP

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering + 2 years experience

Job description

mîrus Consulting Group in Humacao, Puerto Rico, seeks an Engineer to provide technical support for manufacturing and packaging in a GMP environment. The role emphasizes process optimization, validation activities, equipment support, and regulatory compliance.

You will lead CAPA initiatives, perform root cause investigations, use DOE and statistical methods to drive improvements, prepare documentation, and collaborate with Manufacturing, Quality, Validation, and Operations.