Senior Manufacturing Engineer — Onsite & Process Excellence

Experis; Plano (TX); On-site; USD 114,616,320 - 126,077,952; Full time

Job summary

Experis is seeking a Sr. Manufacturing Engineer in Plano, TX for a 12-month, 100% onsite assignment. The role leads complex investigations, drives cross-functional problem solving, and implements robust manufacturing processes with emphasis on quality, yield, and cost reduction.

Responsibilities include leading validations (IQ/OQ/PQ), mentoring junior engineers, and communicating findings to senior leadership while ensuring regulatory compliance with FDA, ISO, and GMP standards.

Qualifications

• Bachelor's degree in Mechanical Engineering (preferred) or related field.
• 5+ years of manufacturing engineering experience, preferably in a regulated industry.
• Experience leading manufacturing support activities and cross-functional projects.
• Experience performing equipment and process validations (IQ/OQ/PQ).
• Experience utilizing structured root cause analysis methodologies and implementing corrective actions.

Responsibilities

• Lead troubleshooting of complex manufacturing, process, and equipment-related issues to minimize downtime and maintain production objectives.
• Analyze yield, scrap, defect, and process performance data to identify trends and drive sustainable improvements.
• Lead root cause investigations using 6M, 5 Why, Fishbone, DOE, and statistical analysis tools.
• Drive continuous improvement initiatives focused on quality, productivity, cost reduction, capacity expansion, and process robustness.
• Lead cross-functional teams in the execution and implementation of CAPA.
• Plan, execute, and document equipment and process validations using IQ/OQ/PQ methodologies.
• Develop and optimize manufacturing processes, work instructions, control plans, and SOPs.
• Provide technical mentorship to junior engineers and manufacturing personnel.
• Assess and implement automation, tooling, and process improvements to enhance efficiency.
• Communicate project status and business impact to stakeholders and leadership.
• Ensure compliance with FDA, ISO, GMP, and internal quality system requirements.

Skills

Advanced problem-solving

Data analysis

Cross-functional leadership

Root cause analysis

Communication

Education

Bachelor's degree in mechanical/industrial/electrical/chemical engineering

5+ years of manufacturing engineering experience

Experience leading manufacturing support activities and cross-functional projects

IQ/OQ/PQ validation experience

Tools

Minitab

JMP

Job description

Experis is seeking a Sr. Manufacturing Engineer in Plano, TX for a 12-month, 100% onsite assignment. The role leads complex investigations, drives cross-functional problem solving, and implements robust manufacturing processes with emphasis on quality, yield, and cost reduction.

Responsibilities include leading validations (IQ/OQ/PQ), mentoring junior engineers, and communicating findings to senior leadership while ensuring regulatory compliance with FDA, ISO, and GMP standards.