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Utilize Mechanical Engineering principles to conceptualize, design and conduct failure analysis on a filling station for liquid drug substances.
In the biopharmaceutical industry, ensuring precise and sterile filling processes is crucial, making it a central task for many entry-level roles. In this Build Project, you'll take on the role of a Mechanical Engineer, where you'll conceptualize, design, and conduct failure analysis for a cutting-edge mechanical filling station. Under the guidance of a seasoned industry expert, you'll tackle real-world challenges related to fluid dynamics, precision engineering, and regulatory compliance. You'll gain hands-on experience with industry-standard tools and methodologies such as Failure Mode and Effects Analysis (FMEA), all within a simulated biopharma team environment that mirrors industry operations.
By the end of the project, you will be able to:
Understand how mechanical engineering and design intersects with regulatory and quality control standards specific to the pharmaceutical industry.
Leverage principles of mechanical engineering to perform failure analysis and risk assessments.
Explore sterile systems and aseptic design.
Getting to know each other. A basic introduction to mechanical engineering and how it is useful in the pharmaceutical industry.
Introduction to pharmaceutical regulations (FDA vs USDA vs EMEA), equipment I/OQ (Installation/Operational Qualification) and cGMP (current good manufacturing practices). An overview of how drug substance (DS) is manufactured at Akston.
Understanding the role of a filling station in converting a DS into a DP (Drug Product). Learning sketching and design fundamentals.
Introduction to FMEA and risk assessment tools used in the industry. Introduction to lean manufacturing ideologies.
Students will present their projects in front of their peers. Students will implement the FMEA concepts from earlier to review their peers’ projects and suggest improvements.
Students will implement the suggestions and make a final presentation.
Preparing mock documentation (brochure/manual) for your report.
Explore various career pathways for mechanical engineers. Tips on developing a profile to get the attention of an employer. Simulated job interviews, etc.
Basic understanding of mechanical engineering and design principles: You should be able to conceptualize and detail mechanical systems, including knowledge of component selection and system integration. Familiarity with concepts covered in classes like Introduction to Mechanical Engineering or Mechanical Design is expected.
Experience with mechanical engineering based failure analysis techniques: You should be comfortable performing Failure Mode and Effects Analysis (FMEA), identifying potential failure points in mechanical systems, and suggesting improvements. Knowledge from classes such as Engineering Risk Analysis or Reliability Engineering will be beneficial.
Familiarity with CAD or mechanical engineering design. You may use any tool to prepare your design, but you should have some familiarity with mechanical design concepts.
Strong technical writing and presentation skills: You should be able to clearly document your design process, analysis, and recommendations in a comprehensive report. Additionally, you should be able to effectively present your findings and engage with a professional audience, skills typically covered in Technical Communication or Presentation Skills courses.
Problem-solving and critical thinking abilities: You should be able to approach complex design challenges analytically, think creatively about solutions, and troubleshoot issues that arise during the project. This involves skills often developed in Mechanical Engineering, Engineering Problem-Solving or Applied Mechanics courses.
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