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Sr Manufacturing Engineer
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 Senior Manufacturing Engineer leads enterprise manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution. The role is expected to operate with a high degree of independence, provide technical leadership to project teams, and mentor junior engineers or technical team members as needed.
Key Responsibilities
Role Summary
The Senior Manufacturing Engineer leads enterprise manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution. The role is expected to operate with a high degree of independence, provide technical leadership to project teams, and mentor junior engineers or technical team members as needed.
Key Responsibilities
- Lead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
- Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.
- Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.
- Manage enterprise manufacturing projects from concept through implementation; lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers as applicable.
- Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
- Lead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
- Provide technical direction for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
- Support change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with site quality procedures.
- Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
- 5-7+ years in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment.
- Strong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
- Electrical and mechanical engineering background applied to automated or semi-automated manufacturing systems.
- Experience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
- Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred.
- Experience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred.
- Experience supporting product introductions, process scale-up, design transfer, and improvements to existing manufacturing processes.
- Strong project management, communication, technical writing, analytical, and cross-functional leadership 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 while providing technical guidance to others as needed.