Engineer - 35778

Mirus Consulting Group; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico seeks an Engineer to support biotechnology manufacturing with a focus on purification processes, including chromatography and UF/DF systems.

You will provide technical support, monitor processes, troubleshoot deviations, and drive continuous improvement while ensuring GMP compliance and safe operations. This role requires hands-on purification technology experience and cross-functional collaboration.

Qualifications

• Master’s degree in Engineering OR Bachelor’s degree in Engineering with 2 years of Engineering experience

Responsibilities

• Provide engineering support for biotechnology manufacturing operations, specifically within purification processes.
• Knowledge of chromatographic and UF/DF manufacturing processes.
• Monitor and evaluate purification process performance to ensure operational efficiency and product quality.
• Support day-to-day manufacturing activities involving chromatography columns, skids, UF/DF systems, and associated process equipment.
• Troubleshoot process deviations, equipment issues, and operational challenges impacting purification performance.
• Analyze process data and recommend improvements to maximize yield, throughput, and process robustness.
• Support investigations, deviations, CAPAs, change controls, and implementation of corrective actions.
• Collaborate with Manufacturing, Quality, Validation, Process Development, and Technical Services teams to resolve process-related issues.
• Ensure all activities are executed in compliance with GMP, safety, and regulatory requirements.

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

We are seeking a motivated and detail-oriented Engineer to support biotechnology manufacturing operations with a focus on purification processes. The successful candidate will provide technical support, process monitoring, troubleshooting, and continuous improvement initiatives to ensure safe, compliant, and efficient manufacturing operations. This role requires hands-on knowledge of purification technologies, including chromatography and ultrafiltration/diafiltration (UF/DF) systems.

Key Responsibilities

• Provide engineering support for biotechnology manufacturing operations, specifically within purification processes.
• Knowledge of chromatographic and UF/DF manufacturing processes.
• Monitor and evaluate purification process performance to ensure operational efficiency and product quality.
• Support day-to-day manufacturing activities involving chromatography columns, skids, UF/DF systems, and associated process equipment.
• Troubleshoot process deviations, equipment issues, and operational challenges impacting purification performance.
• Analyze process data and recommend improvements to maximize yield, throughput, and process robustness.
• Support investigations, deviations, CAPAs, change controls, and implementation of corrective actions.
• Collaborate with Manufacturing, Quality, Validation, Process Development, and Technical Services teams to resolve process-related issues.
• Ensure all activities are executed in compliance with GMP, safety, and regulatory requirements.

Basic Qualifications

• Master’s degree in Engineering OR
• Bachelor’s degree in Engineering and 2 years of Engineering experience

Schedule

Monday to Friday | 8:00 AM - 5:00 PM

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.