JT509 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a manufacturing/process engineer to join our team in the Puerto Rico and USA manufacturing sector. You will develop, optimize, and implement manufacturing processes, provide engineering support to operations, and drive continuous improvement in a world-class setting.

Requirements include a Bachelor's degree in Engineering and 3+ years of related experience, knowledge of process validation, IQ/OQ/PQ, CSV, and root cause analysis; strong technical writing

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3+ years of relevant engineering or manufacturing experience.
• Experience with process validation, equipment qualification, or related areas.
• Knowledge of CSV and IQ/OQ/PQ procedures.
• Experience with investigations and root cause analysis.
• Strong written and verbal communication.
• Bilingual English/Spanish preferred.
• First shift
• 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 layouts.
• Provide engineering support to manufacturing operations and production processes.
• Evaluate processes and equipment to identify opportunities for improvement.
• Support equipment installation, qualification, process validation, and implementation.
• Develop and maintain process documentation, procedures, and technical reports.
• Participate in investigations and root cause analysis; implement corrective actions.
• Apply statistical techniques and data analysis to monitor processes.
• Collaborate with cross-functional teams to meet objectives and timelines.
• Identify and implement continuous improvement opportunities.
• Ensure processes and documentation comply with quality and regulatory requirements.

Skills

Process validation

Root cause analysis

Statistical methods

Documentation

Cross-functional teamwork

Time-management

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering or related field

Tools

IQ/OQ/PQ

CSV

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.