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