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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
The Engineer provides technical engineering support for the operation, troubleshooting, optimization, and modification of HVAC, utility, and facility systems within a regulated pharmaceutical and biotechnology manufacturing environment. This role applies sound engineering principles to resolve operational issues, support maintenance strategies, improve system reliability, and execute facility modifications and capital projects.
The Engineer collaborates closely with Facilities, Maintenance, Manufacturing, Quality, Validation, Environmental Health & Safety (EHS), and external contractors to ensure facility systems operate safely, efficiently, and in compliance with GMP, regulatory, and company requirements.
Important: Weekend support and 12-hour shifts will be required during the implementation phase of projects and operational initiatives.
Essential Responsibilities
Position Summary
The Engineer provides technical engineering support for the operation, troubleshooting, optimization, and modification of HVAC, utility, and facility systems within a regulated pharmaceutical and biotechnology manufacturing environment. This role applies sound engineering principles to resolve operational issues, support maintenance strategies, improve system reliability, and execute facility modifications and capital projects.
The Engineer collaborates closely with Facilities, Maintenance, Manufacturing, Quality, Validation, Environmental Health & Safety (EHS), and external contractors to ensure facility systems operate safely, efficiently, and in compliance with GMP, regulatory, and company requirements.
Important: Weekend support and 12-hour shifts will be required during the implementation phase of projects and operational initiatives.
Essential Responsibilities
- Provide engineering support for facility, utility, and HVAC systems to ensure safe, reliable, and compliant operations.
- Troubleshoot equipment and system performance issues, identify root causes, and implement effective solutions.
- Support preventive and predictive maintenance programs to improve equipment reliability and operational efficiency.
- Develop, review, and update engineering documentation, technical reports, drawings, specifications, and change controls.
- Lead or support facility upgrades, equipment installations, and capital projects from design through implementation.
- Coordinate activities with Facilities, Maintenance, Manufacturing, Quality, Validation, and EHS departments.
- Review and evaluate contractor and vendor work to ensure compliance with project requirements and quality standards.
- Support commissioning, qualification, and validation activities for facility and utility systems.
- Participate in investigations, deviation assessments, CAPAs, and continuous improvement initiatives.
- Ensure facility systems comply with applicable GMP requirements, internal procedures, and regulatory expectations.
- Monitor system performance and recommend improvements to increase reliability, efficiency, and sustainability.
- Applies engineering principles to resolve operational issues, support preventive maintenance strategies, and execute facility modifications and capital projects.
- Provide technical support during audits, inspections, and regulatory assessments.
- Master’s Degree in Engineering; OR
- Bachelor’s Degree in Engineering with a minimum of two (2) years of engineering experience.
- Ability to work in a regulated pharmaceutical, biotechnology, or manufacturing environment.
- Strong technical and problem-solving skills.
- Support weekend and 12 hours shifts.
- Experience supporting HVAC, utility, and facility systems in pharmaceutical, biotechnology, medical device, or other regulated industries.
- Knowledge of GMP, safety, and compliance requirements.
- Experience managing facility modifications, engineering projects, or capital improvements.
- Familiarity with equipment troubleshooting, root cause analysis, and corrective action implementation.