Manufacturing Process Engineer II

Manufacturing Process Engineer II responsible for optimizing manufacturing processes, supporting technology transfer and scale-up, troubleshooting process equipment, and leading process validation and continuous improvement activities in GMP-regulated biopharmaceutical or medical device manufacturing environments.

• Bachelors degree in Engineering or equivalent.
• 3-8 years of engineering experience in a manufacturing or process development environment.
• Strong hands-on mechanical aptitude and troubleshooting skills.
• Experience with process improvement, equipment validation, and project execution.
• Excellent communication and cross-functional collaboration skills.
• Biopharmaceutical manufacturing or medical device manufacturing.
• Filtration systems, TFF, pumps, pressure tanks, UV detectors, and process equipment.
• Technology transfer, process scale-up, and new product introduction.
• GMP manufacturing and cleanroom environments.
• Partner with Manufacturing and R&D to implement and optimize manufacturing processes.
• Support technology transfer from Product Development into Manufacturing.
• Troubleshoot manufacturing equipment and resolve process-related issues.
• Improve processes involving filtration products and systems.
• Develop SOPs, validation documentation, technical reports, and training materials.
• Lead root cause investigations, corrective actions, and continuous improvement projects.
• Collaborate with cross-functional teams to meet production and quality objectives.