JT509 - MANUFACTURING ENGINEER II

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, 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.