Manufacturing Engineer II - Process Validation & Equipment

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join our team in a world-class manufacturing environment spanning the pharmaceutical, biotech, medical devices, and manufacturing sectors. You will design processes, layouts, and procedures for assemblies and equipment, ensure machine efficiency, and contribute to process validation across the lifecycle.

The role emphasizes SOP development, line support, and IQ/OQ/PQ validation, with opportunities to impact product quality and

Qualifications

• Bachelor’s degree in Engineering required.
• 3+ years of relevant experience.
• Process Development and documentation.
• Equipment validation and SOP Development.
• Special Build Documentation and Line Support.
• Experience in IQ/OQ/PQ and/or process validation.
• Process Validation Lifecycle from characterization to performance qualification.
• Change control of Medical Devices.
• SOP Development and Special Build Documentation and Line Support.
• Computer and software validation (CSV).

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure efficient layouts.
• Defines sequence of operations and procedures for fabrication of tools and equipment and other functions affecting product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery and tools to verify efficiency and initiates corrective action to ensure quality.
• Develops manufacturing processes applicable to statistical process control and related techniques.

Skills

Process Development

Documentation

Equipment validation

SOP Development

Line Support

Process Validation

CSV validation

Change control

MES system

Injection molding

Education

Bachelor’s degree in Engineering

Tools

IQ/OQ/PQ

IQ/OQ/PQ/Validation

MES system

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join our team in a world-class manufacturing environment spanning the pharmaceutical, biotech, medical devices, and manufacturing sectors. You will design processes, layouts, and procedures for assemblies and equipment, ensure machine efficiency, and contribute to process validation across the lifecycle.

The role emphasizes SOP development, line support, and IQ/OQ/PQ validation, with opportunities to impact product quality and