Manufacturing Process Engineer II — Validation & SOP

qualityconsultinggroup; Villalba (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico & USA seeks a talented Engineer to design manufacturing processes, machine layouts, and production procedures for assemblies and equipment. You will drive process development, validation, and documentation to support product quality.

With a Bachelor's in Engineering and 3+ years of experience, you will perform IQ/OQ/PQ, SOP development, change control, and MES-related tasks, including injection molding processes.

Qualifications

• Bachelor’s degree in Engineering.
• 3+ years of relevant experience.
• Process Development and documentation.
• Equipment validation.
• SOP Development.
• Special Build Documentation and Line Support.
• Experience in IQ |OQ |PQ and/or process validation.
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification).
• SOP Development | Special Build Documentation and Line Support.
• Computer and software validation CSV.
• Change control of Medical Devices.
• MES system.
• Experience in injection molding processes.
• Shift: 1st shift.

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 most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect 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, 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

Equipment validation

SOP Development

Line Support

IQ/OQ/PQ Validation

CSV Validation

Change control

MES system

Injection molding

Education

Bachelor’s degree in Engineering

Tools

MES system

Job description

Quality Consulting Group, LLC in Puerto Rico & USA seeks a talented Engineer to design manufacturing processes, machine layouts, and production procedures for assemblies and equipment. You will drive process development, validation, and documentation to support product quality.

With a Bachelor's in Engineering and 3+ years of experience, you will perform IQ/OQ/PQ, SOP development, change control, and MES-related tasks, including injection molding processes.