Manufacturing Process Engineer II – Validation & Layout

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is a leading firm in the pharmaceutical, biotech, medical devices, and manufacturing industry seeking a talented engineer to join our team. You’ll work across the world-class manufacturing sector in Puerto Rico and the USA, collaborating with a cross-functional team to drive quality and efficiency.

Responsibilities include designing manufacturing processes and layouts, validating equipment and software, and ensuring compliance with procedures.

Qualifications

• Bachelor’s degree in engineering required.
• 3+ years of relevant experience.
• Process Validation, Equipment IQ and Computer software validation knowledge.
• Technical writing knowledge and communication skills.
• Investigation and root cause analysis skills.
• Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
• Fluent writing skills in English and Spanish for cross-functional meetings.

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 and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment and other functions affecting product performance.
• Adapts machine or equipment design to factory and production conditions.
• Incorporates inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify efficiency and initiates corrective action for quality.
• Develops manufacturing processes applicable to statistical process control.

Skills

Process Validation

Equipment IQ

Software Validation

Technical Writing

Communication

Root Cause Analysis

Statistical Techniques

Bilingual EN/ES

Project Scheduling

Education

Bachelor's in Engineering

Job description

Quality Consulting Group, LLC is a leading firm in the pharmaceutical, biotech, medical devices, and manufacturing industry seeking a talented engineer to join our team. You’ll work across the world-class manufacturing sector in Puerto Rico and the USA, collaborating with a cross-functional team to drive quality and efficiency.

Responsibilities include designing manufacturing processes and layouts, validating equipment and software, and ensuring compliance with procedures.