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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.
Role Summary
The Manufacturing Engineer supports enterprise manufacturing operations by assisting with validation activities, documentation generation, manufacturing instructions, data analysis, and process improvement initiatives under the guidance of senior engineering and cross-functional team members.
Key Responsibilities
Experience Requirements
Role Summary
The Manufacturing Engineer supports enterprise manufacturing operations by assisting with validation activities, documentation generation, manufacturing instructions, data analysis, and process improvement initiatives under the guidance of senior engineering and cross-functional team members.
Key Responsibilities
- Support IQ/OQ/PQ and process performance qualification activities by assisting with validation protocols, reports, test execution, and related documentation.
- Assist in developing in-process and receiving inspection systems, basic control plans, sampling plans, and inspection methods for components and manufacturing processes.
- Generate and maintain equipment documentation, PM/calibration procedures, manufacturing instructions, and process documentation with guidance from senior engineers.
- Support enterprise manufacturing projects from concept through implementation; participate in cross-functional collaboration with Manufacturing, Quality, R&D, Regulatory, and Supply Chain as applicable.
- Apply basic DOE, FMEA/PFMEA, risk analysis, SPC, and root-cause tools to support process characterization, optimization, and improvement.
- Support Lean Manufacturing and continuous improvement activities focused on yield, cycle time, cost, throughput, and process documentation improvements.
- Support manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification under technical supervision.
- Assist with CAPA, nonconformance investigations, change control, and product/process scale-up activities as assigned.
Experience Requirements
- Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
- 1-3 years in manufacturing engineering, process engineering, quality engineering, validation, or related technical experience within an FDA-regulated environment preferred.
- Basic working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices used in regulated manufacturing environments preferred.
- Electrical, mechanical, industrial, or biomedical engineering background applicable to manufacturing systems.
- Exposure to automation/controls, tooling, fixtures, test methods, equipment qualification, or process validation preferred.
- Familiarity with DOE, FMEA/PFMEA, CAPA, root-cause investigation, SPC, and process capability concepts.
- Experience with Microsoft Excel and exposure to Minitab, JMP, or equivalent statistical tools preferred.
- Exposure to Lean Manufacturing, Six Sigma, Kaizen, or other continuous improvement methodologies preferred.
- Exposure to product introductions, process scale-up, design transfer, or improvements to existing processes preferred.
- Strong analytical, communication, teamwork, technical writing, and problem-solving skills.
- Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
- Ensures proper documentation discipline and supports Quality System compliance with guidance from senior engineers and quality partners.