The Manufacturing Engineer supports pharmaceutical and life sciences manufacturing operations by assisting with production equipment, manufacturing processes, process improvements, and technical documentation. The role focuses on improving manufacturing efficiency, maintaining equipment readiness, and ensuring compliance with GMP standards.
Key Responsibilities:
- Provide engineering support for routine pharmaceutical and biotechnology manufacturing operations, including production equipment and manufacturing systems.
- Assist with equipment installation, setup, troubleshooting, and performance monitoring to support uninterrupted manufacturing activities.
- Monitor production processes and equipment performance to identify operational issues and opportunities for improvement.
- Support manufacturing line optimization, process improvement, and waste reduction initiatives to improve productivity and operational efficiency.
- Prepare and update manufacturing documentation, equipment operating procedures, work instructions, and technical records.
- Participate in equipment commissioning, qualification, and validation activities, including support for IQ, OQ, and PQ documentation.
- Coordinate with Production, Maintenance, Quality, and Engineering teams to investigate equipment and manufacturing-related issues.
- Support engineering change controls, deviation investigations, and corrective actions while maintaining the qualified state of manufacturing equipment.
Skills Required:
- Basic understanding of pharmaceutical manufacturing operations, production equipment, and industrial engineering principles.
- Knowledge of GMP, manufacturing documentation, equipment maintenance, and quality compliance requirements.
- Familiarity with manufacturing equipment, process flow diagrams, and basic troubleshooting techniques.
- Understanding of continuous improvement concepts such as Lean Manufacturing, 5S, and root cause analysis.
- Good analytical, communication, documentation, and problem-solving skills with proficiency in Microsoft Office.
Preferred:
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or Biotechnology.
- Internship or academic exposure to manufacturing operations, equipment engineering, or pharmaceutical production.