Engineer - 35631

Mirus Consulting Group; Puerto Rico; On-site; USD 70,000 - 100,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks an Engineer to support biotechnology manufacturing with a focus on downstream purification processes in a GMP environment. You will provide technical expertise, troubleshoot, monitor processes, and drive continuous improvement initiatives.

You will collaborate with Manufacturing, Quality, Validation and Maintenance teams to resolve issues, support equipment qualifications, process validations, and technology transfer activities, while

Qualifications

• Master’s Degree in Engineering or Bachelor’s Degree in Engineering with 2 years of experience.
• Experience supporting biotechnology manufacturing processes, especially purification.
• Knowledge of chromatography and UF/DF technologies; GMP familiarity.

Responsibilities

• Provide engineering support for biotechnology manufacturing processes, specifically purification operations.
• Monitor and optimize downstream processes for quality and efficiency.
• Support operation, troubleshooting and improvement of chromatography and UF/DF systems.
• Analyze process data and identify optimization opportunities.
• Support deviation investigations, CAPAs, and change control activities.
• Collaborate with Manufacturing, Quality, Validation, Maintenance and Technical Services.
• Support equipment qualifications, process validations and technology transfer.
• Ensure GMP, safety and company requirements; develop SOPs and reports.

Skills

Biotech process

Chromatography

UF/DF

Data analysis

Troubleshooting

Cross-functional

Documentation

Education

Master’s Degree in Engineering

Bachelor’s Degree in Engineering

Tools

Chromatography systems

UF/DF equipment

GMP compliance

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 highly motivated Engineer to support biotechnology manufacturing operations with a focus on downstream purification processes. The successful candidate will provide technical expertise, troubleshooting support, process monitoring, and continuous improvement initiatives within a GMP-regulated manufacturing environment.

Key Responsibilities

• Provide engineering support for biotechnology manufacturing processes, specifically purification operations.
• Monitor and optimize downstream processes to ensure product quality, process efficiency, and regulatory compliance.
• Support the operation, troubleshooting, and performance improvement of chromatography and ultrafiltration/diafiltration (UF/DF) systems.
• Analyze process data and identify opportunities for process optimization and operational excellence.
• Support deviation investigations, root cause analyses, CAPAs, and change control activities as required.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Technical Services teams to resolve process issues.
• Support equipment qualifications, process validations, and technology transfer activities as required.
• Ensure compliance with GMP, safety, environmental, and company requirements.
• Develop and revise technical documents, standard operating procedures (SOPs), and engineering reports.

Qualifications

• Master’s Degree in Engineering; OR
• Bachelor’s Degree in Engineering and 2 years of engineering experience.
• Experience supporting biotechnology manufacturing processes, specifically purification operations.
• Working knowledge of chromatography systems and techniques.
• Experience with Ultrafiltration/Diafiltration (UF/DF) operations.
• Familiarity with GMP-regulated environments and pharmaceutical or biotechnology manufacturing.
• Strong problem-solving, analytical, and troubleshooting skills.
• Ability to work effectively in a cross-functional team environment.
• Excellent written and verbal communication skills.

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.