Jt002 - Sr Manufacturing Engineer

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:

• Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes. 
• Support IT teams in testing and implementation of IT system upgrades related to manufacturing equipment.
• Perform Computer System Validation (CSV) activities to ensure systems meet validation and regulatory requirements.
• Assist with documentation updates and change control activities related to manufacturing systems and processes.
• Support integration of IT systems with manufacturing equipment.
• 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.
• Knowledge or experience with IT systems integrated with manufacturing equipment.
• Experience performing Computer System Validation (CSV) activities.
• 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
• Knowledge or experience with IT systems integrated with manufacturing equipment.
• Experience performing Computer System Validation (CSV) activities.

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.