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Senior MS&T Engineer

Fishers Competitive Permanent

Job Responsibilities: 

  • MSAT Engineer is responsible for scaling up and transferring the process into full-scale manufacturing process based on data generated internally or received from the client
  • Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports, and Process FMEA
  • Represents MSAT in project teams and communicate directly with customers. Recognized as a Subject Matter Expert for the manufacturing processes.
  • Author GMP manufacturing documentation including Master Batch Records, Bill of Materials, and Processing Forms
  • Monitor Process Data, identify trends, and propose actions as necessary
  • Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment, and effective corrective and preventive actions
  • Provide technical guidance and oversight to the Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
  • Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing
  • Able to assess the impact of changes to the product, process, equipment, procedures, and/or materials
  • Other responsibilities as required


  • Bachelor’s degree in science or engineering
  • Master’s degree in science or engineering preferred
  • 3+ years of GMP experience required
  • Experience in Technical Transfer for pharmaceutical or related industry


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