JT259 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented Process Engineer to join our team, contributing in a world-class manufacturing environment across Puerto Rico and the USA. You will drive process development, equipment IQ/OQ/PQ, and MES-related activities to ensure product quality and regulatory compliance.

The role emphasizes documentation, DOE with MINITAB, and change control of medical devices, with a first shift in a manufacturing setting. Equal opportunity employer.

Qualifications

• Bachelor’s degree in Engineering.
• 3+ years of relevant experience.
• Process Development and documentation.
• Equipment IQ/OQ/PQ and/or process validation experience.
• DOE experience preferred (with MINITAB).
• CSV/software validation and change control of Medical Devices.
• MES system experience.
• Shift: 1st shift.

Responsibilities

• Working on the introduction on a new product and/or components.
• 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

SOP Development

Equipment validation

OQ/PQ/Validation

DOE (with MINITAB)

CSV validation

Change control

MES system

Line Support

Education

Bachelor’s degree in Engineering

3+ years of relevant experience

Tools

MINITAB

Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Working on the introduction on a new product and/or components
• 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.

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 equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with minitab)
• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices
• MES system
• Shift: 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.