Manufacturing Process Engineer II - Validation & SOPs

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Quality Consulting Group, LLC designs and optimizes manufacturing processes for pharmaceutical, biotech, medical devices, and related industries in the United States and Puerto Rico. You will develop layouts, procedures and validation steps for equipment, while ensuring production meets quality standards and regulatory requirements.

Join a team focused on continuous improvement and GMP adherence, handling process development, line support and documentation across multiple facilities.

Qualifications

• Bachelor’s degree in Engineering is required.
• 3+ years of relevant experience.
• Process development and documentation experience.
• Equipment IQ/OQ/PQ and process validation experience.
• SOP development and special build documentation.
• Experience with injection molding processes.
• Experience with MES systems and CSV validation.
• Ability to work on 1st shift.

Responsibilities

• Designs manufacturing processes, procedures and layouts for assemblies, equipment installation, processing, machining and material handling.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

Skills

Process development

Documentation

SOP development

Line support

Quality systems awareness

Problem-solving

Education

Bachelor’s degree in Engineering

Tools

MES system

IQ/OQ/PQ validation

CSV validation

Change control

Injection molding

Job description

Quality Consulting Group, LLC designs and optimizes manufacturing processes for pharmaceutical, biotech, medical devices, and related industries in the United States and Puerto Rico. You will develop layouts, procedures and validation steps for equipment, while ensuring production meets quality standards and regulatory requirements.

Join a team focused on continuous improvement and GMP adherence, handling process development, line support and documentation across multiple facilities.