Summary: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:- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field. (Degree in progress will be considered)
- 3+ years of experience in a manufacturing engineering role, preferably within the pharmaceutical or life sciences industry.
- Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP, etc.).
- Experience with process design, process control, and equipment validation in a regulated manufacturing environment.
- Proficiency in the use of engineering software, such as AutoCAD, SolidWorks, or process simulation tools.
- Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.
- Excellent problem-solving, analytical, and troubleshooting skills.
- Strong communication and collaboration skills with the ability to work across cross-functional teams.
- Knowledge of statistical process control (SPC), root cause analysis, and design of experiments (DOE) is a plus.
