About the role
The Technical Services and Manufacturing Sciences (TSMS) Principal Device Assembly and Packaging Engineer will be responsible for leading complex device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide advanced technical leadership for secondary manufacturing operations to ensure robust and reliable packaging and device assembly processes are established and executed.
This position will lead the delivery of technical guidance and supervision throughout complex packaging and device assembly processes. The primary objective is to independently establish secondary manufacturing processes for autoinjectors and complex packaging systems that consistently deliver high-quality combination products from clinical through commercial manufacturing.
Essential Job Functions:
* Lead execution of complex packaging and/or device assembly development activities in cross-functional teams with advanced pharmaceutical packaging and combination product development knowledge. Responsible for leading the development of primary, secondary, and tertiary packaging while managing multiple due dates and project timelines from clinical to commercialization across multiple programs
* Lead client team meetings to understand complex packaging requirements and independently develop comprehensive technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA
* Demonstrate advanced understanding of combination devices (auto injectors), packaging materials and manufacturing processes with expertise in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products
* Lead technical troubleshooting and investigations of complex packaging issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions
* Provide advanced technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs with strategic impact
* Serves as senior TSMS representative in project teams and manages direct communications with customers. Recognized as Subject Matter Expert for device assembly and packaging processes across multiple product lines
* Lead authoring of complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms for multiple programs
* Monitor and analyze Process Data across multiple packaging operations, identify trends and implement corrective actions independently
* Lead cross-functional teams in assessing and implementing new packaging technologies and device assembly equipment
* Conduct comprehensive impact assessments of changes to packaging materials, device components, and assembly processes
* Mentor Entry Level engineers and provide technical training on device assembly and packaging best practices
* Other responsibilities as required
Special Job Requirements:
* Bachelor's degree in science, engineering or packaging technology required
* Master's degree in science, engineering or packaging technology preferred
* 5+ years of demonstrated experience in pharmaceutical packaging or combination product development and commercialization
* Advanced experience in global product launches and the associated CMC regulatory requirements
* Strong understanding of regulatory device requirements (DHF, RMF, Design Inputs, Design Outputs, Design Transfer)
* Proven experience in Technical Transfer leadership for pharmaceutical or related industry
* Advanced project management skills with ability to manage multiple complex programs
* Excellent communication skills for client interaction and cross-functional team leadership