Biotech Downstream Purification Engineer (GMP)

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 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