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 development of new pharmaceutical products, delivery devices, and/or drug-device combination products, with emphasis on patient-centered design. Responsibilities include developing suitable product distribution solutions to ensure adequate product protection during shipping against mechanical and thermal hazards (including cold-chain).

Responsibilities

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

Qualifications

• Required: Bachelor’s degree in engineering or science with a minimum of 7 years of experience in packaging engineering and shipping distribution, or Master’s degree with a minimum of 4 years of experience in packaging engineering and shipping distribution; minimum 2 years of GMP-regulated pharmaceutical and/or medical device industry experience; background in sterile barrier and/or deep frozen product packaging.
• Preferred: 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, container closure systems; demonstrated ability to lead cross-functional teams; ability to manage projects and adapt to changing priorities and short lead times.

Skills

• 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
• Strong leadership and cross-functional collaboration
• Effective project management and adaptability to changing priorities