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Engineer - 35631
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
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.
- 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.