Principal Packaging & Device Assembly Engineer

TSMS Engineer – Device Assembly and Packaging Summary The Technical Services and Manufacturing Sciences (TSMS) Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established. This position holds the responsibility of delivering substantial technical guidance and supervision throughout the production process. The primary objective is to establish production processes that are not only robust and reliable but also capable of consistently delivering high-quality products. This entails overseeing the various stages of production, identifying potential areas for improvement, and implementing measures to enhance the overall efficiency and effectiveness of the production operations. Essential Job Functions: • This TSMS Engineer is responsible for the execution of early packaging and/or device assembly development activities in a cross-functional team and requires pharmaceutical packaging and combination product development knowledge. You will be responsible for the development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization. • Meet with client team to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA. • Have a solid understanding of combination devices (auto injectors), packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products is required. • Leads technical troubleshooting and investigations of packaging 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. • Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs. • Author and review of regulatory information packages and filings/submissions. • Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the device assembly and packaging processes. • Help authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms. • Demonstrate ability to engage and effectively influence both internal and external team members across cross-functional groups to prioritize work effectively in a dynamic environment • Monitor Process Data, identify trends and propose actions as necessary. • Other responsibilities as required. Special Job Requirements: • Bachelor’s degree in science, engineering or packaging technology. • Master’s degree in science, engineering or packaging technology preferred. • Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization. • Experience in global product launches and the associated CMC regulatory requirements. • Minimum of 3 years GMP experience required. • Experience in Technical Transfer for pharmaceutical or related industry.