Senior TSMS Engineer

Job Responsibilities:

• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, and Process FMEA. 
• Represents MSAT in project teams and communicates 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 a 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. 

Qualifications:

• Bachelor’s degree in science or engineering. 
• 5+ years of GMP experience within pharmaceutical manufacturing required.  
• Experience in Technical Transfer for the pharmaceutical or related industry is required. 
• Master's degree in science or engineering preferred