
Manufacturing Operations Specialist
11 hours ago
The ideal candidate will have a strong background in biopharmaceutical manufacturing or process design.
Key Responsibilities:- Lead process design, continuous improvement, and optimization of upstream unit operations.
- Develop, review, and approve process documentation.
- Work with cross-functional teams to ensure seamless tech transfer and process implementation.
- Troubleshoot process-related issues during manufacturing campaigns.
- Participate in capital projects involving design or retrofit of biopharmaceutical facilities.
- Evaluate and implement process improvements for robustness, yield, and productivity enhancements.
- Bachelor's, Master's in Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Process Engineering, or a related discipline.
- 5+ years of relevant experience in biopharmaceutical manufacturing or engineering-equipment design.
- In-depth knowledge of upstream operations such as bioreactor operation and centrifugation.
- Exposure to solution preparation, downstream processing is a plus.
- Familiarity with process control systems and PAT tools is advantageous.
- Familiarity to ASPEN, Auto CAD, 3D design along with CMMS tools for asset management.
- Strong understanding of ASME BPE, cGMP, ICH, and regulatory expectations for biopharma manufacturing.
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