Lead Secondary Packaging Development Engineer

Role Summary

Lead Secondary Packaging Development Engineer responsible for the development, qualification, and implementation of secondary packaging solutions and processes in support of new pharmaceutical products, delivery devices, and drug-device combination products, with emphasis on patient-centered design and ensuring product protection during shipping under mechanical and thermal hazards.

Responsibilities

• Partner with Device development, Business Unit, and Human Factor teams to drive patient-centered packaging design requirements.
• Design, develop, and qualify secondary packaging structures (carton, tray, printed materials, labels, adhesives, etc.) for clinical portfolio development and product launch.
• Define and verify product stability requirements against shipping hazards (vibration, shock, vacuum, thermal stresses).
• Develop and qualify shipping containers and packing/shipping processes for clinical environment and commercial launches.
• Develop suitability rationale for secondary packaging and shipping.
• Complete documentation to support tech transfer and regulatory submissions.
• Assess engineering risk for secondary packaging and shipping (e.g., DFMEA, AFMEA).
• Define and establish control strategy elements including specifications and inspection/testing procedures.
• Mentor lower level engineers and contingent workers.
• Drive packaging related technical engineering agenda items and process improvements.
• Incorporate technical advancements and innovations into the portfolio to meet needs of novel drugs and devices.

Qualifications

• Bachelor‚Äôs degree in engineering or science with 7+ years in packaging engineering and shipping distribution, OR Master‚Äôs degree with 4+ years in packaging engineering and shipping distribution.
• Minimum 2 years of work experience in GMP-regulated pharmaceutical and/or medical device industries.
• Background in sterile barrier and/or deep frozen product packaging.

Additional Skills

• Strong technical problem solving with emphasis on patient/consumer-centered design, package functionality, and manufacturability.
• Broad integrated technical knowledge for system and design engineering, product development, and commercialization of pharmaceuticals, medical devices, and container closure systems.
• Demonstrated ability to lead cross-functional teams.
• Effective project management skills and ability to adapt to changing priorities and short lead times.