JT509 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated engineer to join our team in Puerto Rico & USA, focusing on manufacturing processes, validation, and continuous improvement in a world-class environment.

The role involves developing and optimizing processes, supporting equipment qualification, root-cause analysis, and ensuring compliance with quality and regulatory requirements across cross-functional projects.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3+ years of engineering/manufacturing experience.
• Experience in manufacturing, process engineering, validation, equipment qualification, or related areas.
• Knowledge of Process Validation, Equipment IQ/OQ/PQ, and/or CSV preferred.
• Experience with investigation and root cause analysis.
• Knowledge of statistical methods and process improvement techniques.
• Strong technical writing, documentation, and communication skills.
• Ability to work effectively with cross-functional teams.
• Strong organizational and time-management skills with the ability to manage multiple projects and deadlines.
• Bilingual English/Spanish communication skills preferred.
• First Shift

Responsibilities

• Develop, optimize, and implement manufacturing processes, procedures, and production layouts.
• Provide engineering support to manufacturing operations, equipment, and production processes.
• Evaluate manufacturing processes and equipment to identify opportunities for improvement, efficiency, quality, and productivity.
• Support equipment installation, qualification, process validation, and implementation activities.
• Develop and maintain process documentation, procedures, and technical reports.
• Participate in investigations, troubleshooting, root cause analysis, and corrective/preventive actions.
• Apply statistical techniques and data analysis to monitor and improve manufacturing processes.
• Collaborate with cross-functional teams to support manufacturing projects and meet established objectives and timelines.
• Identify and implement continuous improvement opportunities within the manufacturing environment.
• Ensure processes and documentation comply with applicable quality and regulatory requirements.

Education

Bachelor’s degree in Engineering or a related technical field

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:

• Develop, optimize, and implement manufacturing processes, procedures, and production layouts
• Provide engineering support to manufacturing operations, equipment, and production processes
• Evaluate manufacturing processes and equipment to identify opportunities for improvement, efficiency, quality, and productivity
• Support equipment installation, qualification, process validation, and implementation activities
• Develop and maintain process documentation, procedures, and technical reports
• Participate in investigations, troubleshooting, root cause analysis, and corrective/preventive actions
• Apply statistical techniques and data analysis to monitor and improve manufacturing processes
• Collaborate with cross-functional teams to support manufacturing projects and meet established objectives and timelines
• Identify and implement continuous improvement opportunities within the manufacturing environment
• Ensure processes and documentation comply with applicable quality and regulatory requirements

Qualifications:

• Bachelor’s degree in Engineering or a related technical field.
• 3+ years of relevant engineering or manufacturing experience preferred.
• Experience in manufacturing, process engineering, validation, equipment qualification, or related areas
• Knowledge ofProcess Validation, Equipment IQ/OQ/PQ, and/or Computer System Validation (CSV)preferred
• Experience with investigation androot cause analysis
• Knowledge of statistical methods and process improvement techniques
• Strong technical writing, documentation, and communication skills
• Ability to work effectively with cross-functional teams
• Strong organizational and time-management skills with the ability to manage multiple projects and deadlines
• Bilingual English/Spanish communication skills preferred.
• First Shift