Senior Packaging Engineer – Cold Chain Shipping and Condition Monitoring Systems

Arbeitsbeschreibung

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 individual to join the Packaging Engineering team as a Sr. Packaging Engineer I. 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 Engineer will report to the Associate Director of Packaging Engineering.

To create a meaningful partnership with stakeholders and leaders across the corporation, as well as to foster continued professional growth, we would like this Engineer to be based in our global headquarters in Santa Monica, CA and will provide a comprehensive relocation package accordingly.

Responsibilities of the Senior Packaging Engineer – Cold Chain Shipping and Condition Monitoring Systems include:

Package Development -

• Support the development of Kite’s long term packaging strategy and the technologies to meet that plan including experience with:

  • LN2 and preferably LN2 dry vapor shippers and/or

  • Cellular based condition monitoring systems

• Participate in the development and innovation of new cold chain shippers and technology such as:

  • Phase change shippers

  • Cryogenic liquid nitrogen shippers

  • Conditioning monitoring systems

• Research new products and sources for creative devices to expand Kites capabilities

• Identify alternate and new suppliers, as appropriate

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

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

• Provide packaging engineering support for Kite’s cell therapy operations and expansion into allogeneic medicines.

• Support the design, qualification, and use of packaging equipment

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

• Support the development of Kite’s serialization capabilities

• Actively collaborate with internal and external partners

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

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

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

• Comply with the company change control procedures to ensure that only ap-proved packaging materials and processes are used

Quality Record Management -

• Act as a subject matter expert on investigations into complaints/deviations and develop solutions for issues related to logistics, packaging (materials and design), labeling and cold chain transport

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

Basic Qualifications:

MA / MS Degree with 4+ years of Packaging and/or Operations and/or Cold Shipping experience

OR

BA / BS Degree with 6+ years of the aforementioned experience

OR

Associate Degree with 8+ years of the aforementioned experience

OR

High School Diploma / GED and 10+ years of the aforementioned experience

Preferred Qualifications:

• Experience with specification, design, and qualification of pharmaceutical packaging equipment

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

• Energetic, enthusiastic attitude with deep 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

• 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 CAD software to create technical drawings

• Intermediate level proficiency in Microsoft Office applications

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

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