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Senior MS&T Engineer
3 months ago
Job Functions:
- MSAT Engineer is responsible for scaling up and transferring 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 communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes.
- Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
- 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 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.
Candidate Requirements:
- Bachelor’s degree in science or engineering.
- Master’s degree in science or engineering preferred.
- 3+ years GMP experience required.
- Experience in Technical Transfer for pharmaceutical or related industry.
