Senior Manufacturing Engineer: Process & Automation Leader

Select Source International; Plano (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Select Source International is seeking a Sr Manufacturing Engineer to lead complex investigations and driver of continuous improvement in a plan-driven, regulated manufacturing setting in Plano, TX. The role emphasizes data-driven decision making, yield and defect reduction, and robust process implementation.

The engineer will mentor junior staff, liaise with Production, Quality, R&D, and Supply Chain, and ensure compliance with FDA, ISO, GMP requirements while delivering scalable operations.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of manufacturing engineering experience in regulated environments.
• Experience leading cross-functional investigations and CAPA.
• Strong data analysis and problem-solving skills, able to drive decisions.
• Fluent English for meetings, documentation, and presentations.

Responsibilities

• Lead troubleshooting of complex manufacturing and equipment issues to minimize downtime.
• Analyze yield, scrap, defects, and performance data to identify trends and improvements.
• Lead root cause investigations using structured methodologies (6M, 5 Why, DOE).
• Drive continuous improvement on quality, productivity, cost, and capacity.
• Coordinate CAPA with cross-functional teams and document actions.
• Plan and document validations using IQ/OQ/PQ; develop SOPs and control plans.
• Mentor junior engineers and provide technical guidance to manufacturing personnel.
• Assess automation, tooling, and process improvements for efficiency.
• Communicate project status and business impact to leadership.
• Ensure compliance with FDA, ISO, GMP and internal quality systems.

Skills

Advanced problem-solving

Data analysis

Cross-functional leadership

Root cause analysis

Communication skills

Education

Bachelor's degree in Mechanical Engineering or related

Tools

Minitab

JMP

Job description

Select Source International is seeking a Sr Manufacturing Engineer to lead complex investigations and driver of continuous improvement in a plan-driven, regulated manufacturing setting in Plano, TX. The role emphasizes data-driven decision making, yield and defect reduction, and robust process implementation.

The engineer will mentor junior staff, liaise with Production, Quality, R&D, and Supply Chain, and ensure compliance with FDA, ISO, GMP requirements while delivering scalable operations.