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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 support to manufacturing operations, equipment, processes, and systems within a regulated pharmaceutical/biotechnology environment. This role applies engineering principles and technical expertise to troubleshoot operational issues, improve processes, support manufacturing and quality systems, and execute engineering projects of moderate scope and complexity. The successful candidate will work cross-functionally with Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, and Process Development teams to ensure safe, compliant, and efficient operations.
Key Responsibilities
Education
Position Summary
The Engineer provides technical support to manufacturing operations, equipment, processes, and systems within a regulated pharmaceutical/biotechnology environment. This role applies engineering principles and technical expertise to troubleshoot operational issues, improve processes, support manufacturing and quality systems, and execute engineering projects of moderate scope and complexity. The successful candidate will work cross-functionally with Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, and Process Development teams to ensure safe, compliant, and efficient operations.
Key Responsibilities
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques, principles, and procedures under general supervision.
- Assistance given for unusual problems.
- Serve as a technical expert to processes, equipment, and/or systems during troubleshooting operations and cross-functional discussions.
- Actively support daily manufacturing operations when required to meet production schedules and resolve complex operational issues.
- Routinely supervise manufacturing processes for performance indicators and operations.
- Suggest problem resolution and provide troubleshooting mentorship.
- Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, Validation, and other functional groups to develop requirements and recommendations for process and system modifications.
- Support the execution of manufacturing and quality systems, including:
- Deviations
- Equipment Qualification
- Process Validation
- Standard Operating Procedures (SOPs)
- Training Programs
- New Product Introductions (NPI)
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- Organize, analyze, interpret, and present technical data related to operational issues or engineering projects of moderate scope and complexity.
- Apply engineering principles to the design and implementation of system modifications, experiments, and/or capital projects.
- Ensure activities are executed in compliance with applicable regulatory requirements, company standards, and safety guidelines.
Education
- Master’s Degree in Engineering; OR
- Bachelor’s Degree in Engineering with a minimum of two (2) years of engineering experience.
- Mechanical Engineering
- Electrical Engineering
- Chemical Engineering
- Support a 24/7 manufacturing operation, including non-standard shifts, extended hours, weekends, and holidays as required by business needs.
- Technical Problem Solving
- Analytical Thinking
- Process Improvement
- GMP Compliance Awareness
- Cross-Functional Collaboration
- Communication and Presentation Skills
- Results Orientation
- Attention to Detail
- Organizational Effectiveness
- Continuous Learning and Innovation