United States flag

Experienced Senior Packaging Engineer

United States - Maryland - FrederickManufacturing Operations & Supply ChainRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated and organized individual to join Packaging Engineering team as a Sr. Packaging Engineer II.  As part of this role, the incumbent will support the design, development, qualification, and implementation of packaging materials and systems along with the investigation of packaging/shipping deviations.

The Senior Packaging Engineer will report to the Associate Director of Packaging Engineering and be based out of our brand new, state-of-the-art Cell Therapy Commercial Manufacturing Facility in Frederick, MD.

Responsibilities of the Experienced Senior Packaging Engineer include:

  • Package Development:

    • Provides packaging engineering support for Kite’s cell therapy operations in to support growth and increased volumes at Kite’s Fredrick, Maryland Facility

    • Effectively manages packaging related projects (Change Control, CAPA) to support increased volumes at Kite manufacturing sites 

    • Provides support for lifecycle management of packaging components by creating processes and systems that are scalable for rapidly increasing volumes

    • Identifies alternate suppliers, as appropriate

    • Qualifies shipping lanes and processes to support expanded volumes to ensure the safe delivery of life-saving therapies

    • Actively collaborates with internal and external partners

    • Writes package material specifications and packaging process instructions for new and existing packaging

    • Supports the design, qualification, and use of label printing and application equipment

    • Utilizes industry best practices to conduct the design, development, qualification, and implementation of packaging and labeling materials and systems for temperature-controlled, sterile products

    • Writes engineering test protocols, execute testing in conjunction with internal partners and third-party laboratories, and write engineering test summary reports

    • Maintains awareness of all government regulations as they pertain to packaging and labeling materials, components, processes, and products

    • Works closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging and labeling solutions

    • Complies with the company change control procedures to ensure that only approved packaging materials and processes are used

  • Warehouse, Manufacturing Site Support, and 3PL Packaging Support

    • Provides leadership and direction to Kite’s Fredrick, Maryland supply chain organization to support increased volumes

    • Provides packaging and shipping expertise to support both internal and external logistics and supply chain partners

    • Works closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging and labeling solutions

  • Quality Record Management

    • Investigates complaints/deviations and develop solutions for issues related to logistics, packaging (materials and design), labeling and cold chain transport

    • Works closely with quality partners to develop effective CAPAs to reduce rate of deviations in support of increasing shipment volumes

Basic Qualifications:

PhD

OR

MA / MS degree with 6+ years of Packaging and/or Engineering and/or Supply Chain and/or Operations and/or cGMP experience

OR

BS / BA degree with 8+ years of Packaging and/or Engineering and/or Supply Chain and/or Operations and/or cGMP experience

OR

High School Degree with 12+ years of Packaging and/or Engineering and/or Supply Chain and/or Operations and/or cGMP experience

Preferred Qualifications:

  • Bachelor of Science Degree in Mechanical, Industrial, Packaging, Chemical, Biomedical Engineering, and/or a related field

  • 8+ years of package engineering experience

  • Ability to work independently with limited supervision as the site packaging lead in a hybrid office/home work environment

  • Ability to be on site a minimum of 2 days per week, more if required, at Kite’s Fredrick, Maryland site

  • Knowledge of 21 Code of Federal Regulations, cGMP’s, and other applicable FDA Regulatory requirements

  • Knowledge of U.S., Japanese, and European Compendia requirements as they pertain to packaging materials, components, processes, and products

  • Knowledge of pharmaceutical packaging and transport

  • Cold Chain / hazardous material packaging and shipping experience desired

  • Project Management training/certification desired

  • Knowledge of statistical methods and software desired

  • Knowledge of CAD software to create technical drawings

  • Knowledge with intermediate level proficiency in Microsoft Office applications

  • Strong written and verbal communication skills, both interpersonal and business-related

  • Energetic, enthusiastic attitude with strong desire to learn new skills

  • The ability to propagate a culture of organization and timeliness in the management of project tasks, schedules, and risks

  • Ability to successfully operate in a fast paced and dynamic cross-functional environment

Does this sound like you? If so, please apply today!

#LI-MF1

#WH123MD