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, Billof 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.

• 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