MANUFACTURING ENGINEER II

02 ott - Villalba
Quality Consulting Group

QUALITY CONSULTING GROUP, a leader in the 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 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.
- Stron

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