Engineer - 35737

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 is a local company in Humacao, Puerto Rico, that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations in Puerto Rico and parts of the United States. The company assesses and validates automation equipment, network infrastructure, and business processes, and also manages related projects.

Position Summary

The Engineer is responsible for providing technical support to manufacturing and packaging operations within a GMP-regulated environment. This role focuses on process optimization, validation activities, equipment support, root cause investigations, and implementation of corrective actions to ensure operational excellence, product quality, and regulatory compliance.

Key Responsibilities

• Provide engineering support for manufacturing and packaging operations to ensure safe, compliant, and efficient production processes.
• Support process characterization, validation, monitoring, and optimization activities to improve operational performance and product quality.
• Troubleshoot technical issues and lead root cause investigations using sound engineering principles and problem-solving methodologies.
• Identify, develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to address process deviations and improve system performance.
• Analyze process data using statistical tools and Design of Experiments (DOE) methodologies to support process improvements and decision-making.
• Prepare and review technical documentation, reports, protocols, and investigations in compliance with GMP requirements.
• Collaborate with cross-functional teams including Manufacturing, Quality, Validation, and Operations to support projects and continuous improvement initiatives.
• Evaluate equipment and process performance, providing recommendations for optimization, reliability, and compliance.
• Ensure engineering activities are executed in accordance with site procedures, regulatory requirements, and quality standards.
• Support special projects, audits, inspections, and operational initiatives as required.

Minimum Qualifications

• Master’s degree in Engineering; OR
• Bachelor’s degree in Engineering and two (2) years of engineering experience.
• Experience working in a GMP-regulated environment within the pharmaceutical, biotechnology, or medical device industry.
• Bilingual proficiency in Spanish and English (verbal and written).
• Proficiency in technical report writing .
• Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays as required.

Shift

• 1st or 2nd Shift (must be available to support non-standard schedules as business needs require)

The Company is an equal employment opportunity employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, or disability. Employment opportunities depend solely on each candidate’s qualifications.