MSAT Engineer

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

Qualifications:

· Bachelor’s degree in science or engineering

· Master’s degree in science or engineering preferred

· 1+ years of GMP experience required

· Experience in Technical Transfer for pharmaceutical or related industry