Manufacturing Engineer

The Manufacturing Engineer will play a crucial role in the design, optimization, and troubleshooting of manufacturing processes to ensure efficient, safe, and high-quality production of pharmaceutical products. This position requires hands on trouble shooting of electromechanical packaging equipment. This position involves close collaboration with cross-functional teams to support process improvement, compliance with regulatory requirements, and continuous improvement in a highly regulated environment.

Key Responsibilities :

• Process Optimization : Design, develop, and implement processes to improve manufacturing efficiency, reduce waste, and enhance product quality. Troubleshoot and resolve production issues to minimize downtime and ensure smooth operations.
• Equipment and Technology Management : Evaluate, select, and oversee the installation and maintenance of manufacturing equipment, ensuring they are functioning according to specifications and industry standards.
• Compliance and Documentation : Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards. Maintain accurate records, reports, and documentation in accordance with regulatory guidelines.
• Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc.
• Quality Control and Assurance : Collaborate with quality assurance teams to identify and implement corrective actions, conduct root cause analysis for quality issues, and ensure continuous product quality in the production process.
• Project Management : Lead or participate in cross-functional teams for process improvement, facility upgrades, or new product introduction projects. Provide technical guidance on new product development and scale-up processes.
• Training and Support : Train and mentor operators and technicians on new processes, equipment, and safety procedures to ensure effective and efficient production workflows.
• Continuous Improvement : Identify opportunities for process automation, cost reduction, and other performance improvements. Foster a culture of continuous improvement using Lean, Six Sigma, or similar methodologies.
• Troubleshooting : Provide engineering support during production to resolve mechanical, electrical, or process-related problems in a timely manner.
• Safety and Risk Management : Promote a safe working environment by adhering to health and safety protocols and identifying any potential risks or hazards in the manufacturing processes.

Required Qualifications :

Preferred Qualifications :

Physical Requirements :

SUPERVISORY RESPONSIBILITIES

Supervision of outside contractors, including OEM technicians, specialists and facility contractors where necessary.