JT509 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 65,000 - 85,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC conducts engineering-driven manufacturing initiatives across the pharma, biotech, medical devices, and commercial sectors in the US and Puerto Rico. The role focuses on developing, refining, and validating manufacturing processes, with emphasis on documentation, regulatory compliance, and quality objectives.

The position requires 3+ years of related experience, strong problem-solving skills, and collaboration with diverse teams.

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 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 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

Process Validation

Equipment IQ/OQ/PQ

CSV

Root Cause Analysis

Statistical Methods

Process Improvement

Technical Writing

Documentation

Cross-functional Collaboration

Time Management

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

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.