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Katalyst Healthcares & Life Sciences

Manufacturing Process Engineer II

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Job Description

Roles and Responsibilities:
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.
Education and experience:
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.