Manufacturing Process Engineer II — Optimize & Validate

qualityconsultinggroup; Villalba (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a skilled engineer to join our team in Puerto Rico & USA, focusing on manufacturing process development, optimization, and validation. You will support equipment qualification, process validation, troubleshooting, and documentation, collaborating across functions to meet timelines in a world-class manufacturing setting.

Ideal candidates have a Bachelor’s in Engineering, 3+ years of related experience, and strong analytical, writing, and bilingual

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3+ years of relevant engineering or manufacturing experience preferred.
• Experience in manufacturing, process engineering, validation, equipment qualification, or related areas.
• Knowledge of Process Validation, Equipment IQ/OQ/PQ, and/or Computer System Validation (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.

Skills

Root cause analysis

Statistical methods

Cross-functional collaboration

Documentation

Time management

Bilingual English/Spanish

Education

Bachelor's degree in Engineering

Tools

CSV

IQ/OQ/PQ

Process Validation

Job description

Quality Consulting Group, LLC is seeking a skilled engineer to join our team in Puerto Rico & USA, focusing on manufacturing process development, optimization, and validation. You will support equipment qualification, process validation, troubleshooting, and documentation, collaborating across functions to meet timelines in a world-class manufacturing setting.

Ideal candidates have a Bachelor’s in Engineering, 3+ years of related experience, and strong analytical, writing, and bilingual