TSMS Engineer

The TSMS Technical Transfer Engineer supports the successful transfer, scale-up, and lifecycle management of clinical and commercial manufacturing processes in a cGMP environment. This role partners closely with Operations, Validation, Quality, and external customers to ensure manufacturing processes are robust, well-documented, and capable of reliable commercial execution.

The Technical Transfer Engineer provides hands-on technical support across tech transfer, process validation, GMP floor support, and continued process verification, serving as a key technical resource throughout the manufacturing lifecycle.

• Lead and execute technical transfer activities, including process scale-up from development or client-provided data into full-scale GMP manufacturing
• Select appropriate manufacturing equipment and single-use components, and develop comprehensive technical documentation such as Tech Transfer Plans, Gap Assessments, Process Flow Diagrams, Summary Reports, and Process FMEAs
• Serve as a TSMS representative on cross-functional project teams and act as a technical point of contact for customers
• Author and review GMP manufacturing documentation, including Master Batch Records, Bills of Materials, and processing forms
• Monitor and analyze process data, identify trends, and recommend actions to maintain process control and performance
• Lead technical troubleshooting and investigations, including root cause analysis, product impact assessments, and CAPA development
• Provide technical guidance and oversight to Operations and Validation teams during Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
• Collaborate cross-functionally to assess, implement, and support new technologies within GMP manufacturing
• Evaluate and assess the impact of changes to product, process, equipment, materials, and procedures
• Manage timelines and prioritize critical tasks to support on-time project execution
• Perform additional duties as required to support manufacturing and project objectives

• Bachelor’s degree in Science or Engineering
• Master’s degree in Science or Engineering (preferred)
• 2–3 years of experience in a pharmaceutical manufacturing environment
• Experience supporting technical transfer within pharmaceutical, biotech, or related regulated industries in a client-facing role