Manufacturing Process Engineer — Validation & CI

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

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join our team, contributing to world-class manufacturing across Puerto Rico and the USA. You will develop, optimize, and validate processes, support equipment qualification, and drive continuous improvement in a collaborative environment.

The role requires a Bachelor’s in Engineering and 4+ years of manufacturing experience, with knowledge of validation, CSV, and root-cause analysis.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• 4+ 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 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.
• Bilingual English/Spanish communication skills preferred.

Responsibilities

• Develop, optimize, and implement manufacturing processes, procedures, and layouts.
• Provide engineering support to manufacturing operations, equipment, and production processes.
• Evaluate 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 actions.
• Apply statistical techniques and data analysis to monitor and improve processes.
• Collaborate with cross-functional teams to support projects and timelines.
• Identify and implement continuous improvement opportunities within manufacturing.
• Ensure processes and documentation comply with quality and regulatory requirements.

Skills

Process validation

IQ/OQ/PQ

CSV

Root cause analysis

Statistical methods

Data analysis

Cross-functional teamwork

Technical writing

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering or related field

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join our team, contributing to world-class manufacturing across Puerto Rico and the USA. You will develop, optimize, and validate processes, support equipment qualification, and drive continuous improvement in a collaborative environment.

The role requires a Bachelor’s in Engineering and 4+ years of manufacturing experience, with knowledge of validation, CSV, and root-cause analysis.