Device Assembly & Packaging Engineer

This position will support the delivery of technical guidance and assistance throughout packaging and device assembly processes. The primary objective is to assist with establishing secondary manufacturing processes for autoinjectors and complex packaging systems that consistently deliver high-quality combination products from clinical through commercial manufacturing.

Essential Job Functions

• 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.
• 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.
• 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.
• Assists technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• 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.
• 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.
• Understanding of regulatory device requirements (DHF, RMF, Design Inputs, Design Outputs, Design Transfer).
• Minimum 1 year of GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.
• Functional knowledge of regulatory requirements and industry guidance applicable to CGMPs for Combination Products, including 21 CFR Part 4 Regulation of Combination Products and FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.
• Awareness of industry trends and best practices, current regulatory landscape including FDA actions/activities, and advanced regulatory requirements and industry guidance applicable to CGMPs for Combination Products including EU Medical Device Regulation (EU MDR 2017/745) and ISO 14971:2019 Medical devices — Application of risk management to medical devices.
• SME on risk management and validation of medical devices.