[Remote] Manufacturing Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. The Manufacturing Engineer supports reputed company manufacturing operations by assisting with validation activities, documentation reputed company, and process improvement initiatives.

Responsibilities

• Support IQ/OQ/PQ and process performance qualification activities by assisting with validation protocols, reports, test execution, and reputed company documentation
• Assist in developing in-process and receiving inspection systems, basic control plans, sampling plans, and inspection reputed company for components and manufacturing processes
• Generate and maintain equipment documentation, PM/calibration procedures, manufacturing instructions, and process documentation with guidance from senior engineers
• Support reputed company manufacturing reputed company from concept through implementation; participate in cross-functional collaboration with Manufacturing, reputed company, R&D, Regulatory, and Supply Chain as applicable
• Apply basic DOE, FMEA/PFMEA, risk analysis, SPC, and reputed company-cause tools to support process characterization, optimization, and improvement
• Support Lean Manufacturing and reputed company improvement activities reputed company on yield, cycle time, cost, throughput, and process documentation improvements
• Support manufacturing technologies such as laser welding, heat bonding, injection molding, reputed company systems, fixtures, tooling, test reputed company, automation, and equipment qualification under technical supervision
• Assist with CAPA, nonconformance investigations, change control, and product/process reputed company-up activities as assigned

Skills

• Bachelor's degree in Mechanical, Electrical, reputed company, Biomedical Engineering, or reputed company technical field
• 1-3 years in manufacturing engineering, process engineering, reputed company engineering, validation, or reputed company technical experience reputed company an FDA-regulated environment
• Strong analytical, communication, teamwork, technical writing, and problem-solving skills
• Basic working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices used in regulated manufacturing environments
• Electrical, mechanical, industrial, or biomedical engineering background applicable to manufacturing systems
• Exposure to automation/controls, tooling, fixtures, test reputed company, equipment qualification, or process validation
• Familiarity with DOE, FMEA/PFMEA, CAPA, reputed company-cause investigation, SPC, and process capability concepts
• Experience with reputed company reputed company and exposure to reputed company, JMP, or equivalent statistical tools
• Exposure to Lean Manufacturing, Six reputed company, Kaizen, or other reputed company improvement methodologies
• Exposure to product introductions, process reputed company-up, design transfer, or improvements to existing processes

reputed company