Process Engineering Specialist in Manufacturing Sciences

2 weeks ago


San Diego, California, United States Web-atrio Full time
Position Overview

As a Process Scientist/Process Engineer within the Manufacturing Sciences team at Web-atrio, you will play a pivotal role in the successful execution of mRNA Drug Product therapies for both clinical and commercial cGMP manufacturing.

Key Responsibilities
  • Support the Tech Transfer, Process Validation, and GMP Manufacturing phases to ensure seamless implementation of processes.
  • Conduct various scale-up and technology transfer project tasks, including evaluating process scalability, facility compatibility, and equipment capabilities.
  • Lead cross-functional technology transfer teams and manage projects related to New Product Introduction, Process Performance Qualification, and Product Lifecycle Management.
  • Provide technical guidance and expertise in areas such as buffer formulation, sterile filtration, TFF, and Fill/Finish/Lyophilization/Packaging.
  • Drive investigations, manage change control, optimize processes, troubleshoot technical issues, and implement manufacturing process modifications.
  • Contribute to process FMEA, conduct gap assessments, and develop control strategy documentation.
  • Author and review essential documents, including batch records, tech transfer reports, bills of materials, process descriptions, project reports, engineering specifications, and summary reports.

This role is essential for advancing our manufacturing capabilities and ensuring the highest quality standards in our product offerings.



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