JT041 - MANUFACTURING ENGINEER

Quality Consulting Group, LLC; Puerto Rico; Hybrid; USD 70,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a production support engineer to join our team operating across Puerto Rico and the USA in a world-class manufacturing environment.

You will address testing methods, procedures, device/product yield issues, and perform change control activities, while collaborating with IT, Manufacturing, Engineering and Quality to ensure compliance with validation procedures and regulatory standards.

Qualifications

• Requires a Bachelor's degree in engineering.
• Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments.
• Ability to support project schedules including overtime and weekend work when required.
• Experience with CSV, manufacturing system integration, IT systems in manufacturing, and validation/change management.

Responsibilities

• Responsible for production support engineering with respect to testing methods, procedures, and problems; device/product and yield problems; analysis of product rejection; supplier related engineering changes and optimizing production relative to cost constraints.
• Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes.
• Assist with documentation updates and change control activities related to manufacturing systems and processes.
• Ensure compliance with internal quality systems, validation procedures, and regulatory standards.
• Collaborate with cross-functional teams including IT, Manufacturing, Engineering, and Quality to support project execution.

Skills

Project scheduling

Education

Bachelor's degree in engineering

Tools

CSV (Computer System Validation)

Manufacturing Equipment System Integration

IT Systems in Manufacturing Environments

Validation Documentation & Change Management

Job description

QUALITY CONSULTING GROUP, a leader inthe 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:

• Responsible for production support engineering with respect to testing methods, procedures, and problems; device/product and yield problems; analysis of product rejection; supplier related engineering changes and optimizing production relative to cost constraints.
• Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes.
• Assist with documentation updates and change control activities related to manufacturing systems and processes.
• Ensure compliance with internal quality systems, validation procedures, and regulatory standards.
• Collaborate with cross-functional teams including IT, Manufacturing, Engineering, and Quality to support project execution..

Qualifications:

• Bachelor's degree in engineering
• Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments.
• Ability to support project schedules including overtime and weekend work when required.
• Computer System Validation (CSV)
• Manufacturing Equipment System Integration
• IT Systems in Manufacturing Environments
• Validation Documentation and Change Management

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.