Packaging Engineer

Position Overview

The Packaging Engineer supports the development, transfer, validation, and ongoing optimization of device assembly and pharmaceutical packaging operations for both clinical and commercial products. This role partners with cross-functional teams to establish and maintain robust secondary manufacturing processes while ensuring compliance with current Good Manufacturing Practices (cGMP). The position provides technical leadership across technology transfer, process validation, manufacturing support, and continued process verification activities, with a focus on combination products and advanced packaging systems.

Key Responsibilities

• Support the establishment and development of packaging and device assembly capabilities for commercial manufacturing operations.
• Contribute to the development and implementation of primary, secondary, and tertiary packaging solutions while managing project timelines and deliverables.
• Collaborate with internal stakeholders to define packaging and assembly requirements and generate technical documentation, including Technical Transfer Plans, Process Flow Diagrams, Gap Assessments, pFMEAs, Summary Reports.
• Provide technical expertise for combination products, including autoinjector assembly and pharmaceutical packaging operations.
• Support the selection, qualification, and implementation of packaging and labeling materials for new product introductions.
• Assist with troubleshooting manufacturing and packaging issues, performing root cause investigations, and developing corrective and preventive actions (CAPAs).
• Author and maintain GMP manufacturing documentation, including batch records, bills of materials, and process instructions.
• Monitor process performance, analyze manufacturing data, identify trends, and recommend process improvements.
• Participate in cross-functional project teams and serve as a technical resource for device assembly and packaging operations.
• Support additional technical and operational initiatives as needed.

Qualifications

• Bachelor's degree in Engineering, Packaging Technology, Pharmaceutical Sciences, or a related technical discipline.
• Experience supporting pharmaceutical packaging, medical device assembly, or combination product manufacturing.
• Knowledge of technology transfer, process validation, and commercial manufacturing support within a regulated environment.
• Familiarity with combination product and medical device documentation, including design history and risk management practices.