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Packaging Engineer

Company: Cryoport Systems, Inc.
Location: Irvine
Posted on: November 22, 2021

Job Description:

Packaging Engineer Position Transport to a fulfilling career at Cryoport If you're interested in joining our team, please send your resume and cover letter to-- .--Make sure to include the job title of the position you are interested in the subject line of your email.--

Job Title: Packaging Engineer
Job Category: Staff
Department/Group: Consulting Services
FLSA Status:--Exempt
Reports To: Global VP of Consulting Services
Travel Required: Up to 10% Cryoport & Cryoport Consulting Services
Cryoport is the life sciences industry's most trusted provider of temperature-controlled logistics solutions, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport's proprietary Cryoport Express -- liquid nitrogen dry vapor shippers, innovative C3 --- 2-8--C solution, Cryoportal -- logistics management platform, leading-edge Smartpak II -- condition monitoring system and geo-sensing technology paired with unparalleled cold chain expertise and 24/7/365 customer support, make Cryoport the end-to-end cold chain logistics partner that you can trust. Our Consulting Services cross-functional team assists life science and regenerative medicine clients across all phases of clinical and commercial development with a spectrum of offerings aimed at understanding, quantifying and reducing cold-chain supply chain, logistics and/or packaging risks. We offer a suite of ever-expanding client-customized offerings including:

  • Packaging validation and testing (including laboratory and shipping lane qualification)
  • Physical and Thermal Performance Testing - ISTA, ASTM, IATA
  • Comprehensive Shipping Lane Studies and Qualifications
  • Innovative Packaging and Accessory Design to comply with industry and Cryoport standards
  • Flexible training - recorded, live, on-site, tailored manuals
  • Tailored SOP creation
  • Data Services - carrier performance, reports, data streams, dashboards and analyses
  • Trade and Regulatory Compliance - lane assessments, classification assistance, government agency advisory, documentation review, customs shipment issues, landed cost determination, other advisory
  • Custom Advisory Projects - custom shipper development, issue troubleshooting, cold chain logistics advisory Position Summary
    Client-facing Packaging Engineer reporting to the Global VP Consulting Services organization and directly interacting with clients as well as across Cryoport's teams, including close collaboration and working with Engineering, Operations/Logistics, and Quality departments; daily collaboration with Consulting Services and Consulting Services Program Management colleagues. Role will support the Global VP of Consulting Services for client engagement, development of streamlined processes and tools to support Consulting Services Offerings around the development and support of packaging and accessory design and development for clients across Cryoport Consulting Services and Cryoport BioServices as well as collaborative working with Cryoport Engineering on innovative new projects. This position will focus mainly on the design, development and execution of innovative packaging, labeling and accessories that have high usability, industry-leading functionality, and work across cold chain logistics/distribution (across all temperature bands - controlled room temperature, frozen, ultra-frozen and cryogenic). Materials that will be utilized can range from HDPE sheet, other polymers (thermoformed, blown, injection molded, rotomolded), sheet metal (aluminum, stainless steel). All packaging, labeling and accessories must function across the intended temperature ranges required by our clients (and supported by Cryoport). Packaging must be designed for multiple types of shipping systems (and temperature ranges) and can include boxes/cartons, inserts, bags, racking, cassettes/canisters/vials, customized immobilization elements, development of custom kits for BioServices, etc. Experience with labeling, label testing and labeling challenges across the cold chain (all the way to cryogenic temperatures) is highly valued and desired. All packaging and accessory development should meet the requirements of ISO 21973 Biotechnology - General requirements for transportation of cells for therapeutic use. We are seeking candidates who are interested in being a part of an organization that always serves the needs of our clients and endeavors to create innovative, easy to use solutions which deliver value and ensure the safe packaging and delivery of the critical lifesaving therapies we support every day. We are one of the fastest growing parts of a hyper-growth organization serving the complex challenges of our clients with terrific opportunity for growth for the intellectually curious and those who love to work with clients to collaboratively deliver impactful solutions. The ideal candidate must have excellent communications, organizational skills, time-management skills, and both strong written and verbal communication skills (We ask for a sample of your writing/communications abilities). Must be self-motivated, possess a comprehensive project ownership mentality, but also possess the ability to work within a team environment, both contributing to, as well as receiving information from, the group and working seamlessly in a client facing and focused role for supporting Consulting Services packaging clients and in the support and development of Cryoport's future packaging development vision. Roles and Responsibilities:
    • Design, develop, prototype, manage manufacturing of innovative cold-chain packaging and accessory solutions
    • Rapidly develop client and Cryoport solutions using industry standard software tools like ArtiosCAD, Inventor, Solidworks, etc.
    • Ability to manage in a fast-paced, client-focused environment with multiple simultaneous projects, short deadlines, changing priorities, changing timelines and client needs.
    • A solid understanding of Thermodynamics, -Thermal transfer and heat transfer with a focus on ultra-cold temperatures
    • Good knowledge and experience with a wide variety of packaging materials (for the cold chain), packaging and processing equipment.
    • Ability to bring together multiple solution requirements together to create innovative packaging solutions
    • Drive to ensure all product elements are executed to scope, budget and time
    • Approach all client and Cryoport challenges with strong technical and design competence and a focused on delivering cost effective and timely solutions
    • Strong knowledge of current best practice package test methods and assist with packaging qualification planning, protocol creation, testing, report creation and risk assessment.
    • Ensure packaging solutions are developed with the understanding of needed preconditioning, packout/load, handling, monitoring, unload and distribution.
    • Communicate with clients and understand client solution needs and provide assessment of packaging needs and risks
    • Ability to rapidly assimilate client requirements and solution needs and quickly develop multiple solutions for Cryoport team and client review (considering primary packaging, handling and temperature requirements, therapy specific dosing and packaging needs, shipper and thermal constraints, Cryoport best practices for cold chain products and packaging, etc.).
    • Engage and manage (with and through our global procurement organization) Cryoport manufacturing partners, converters and other solution partners to ensure packaging and accessories are built to defined specifications/design, on time and
    • Engage / manage manufacturing and solution partners to cost effectively and efficiently deliver to specified drawings and design specifications.
    • Develop optimized packaging manufacturing, handling, conditioning, loading and unloading processes.
    • Develop comprehensive SOPs, repeatable and efficient processes, internal operating procedures, work instructions,
    • Develop Engineering Change Orders for new packaging products and accessories and follow Cryoport defined processes to ensure consistent product development, engineering and quality requirements are met and developed products are available to clients when production is complete
    • Support clients in the development of handling, loading, unloading, preconditioning and other training to understand and optimally use developed packaging and accessory solution
    • Support label design and development needs by clients across Cryoport and Bioservices.
    • Assist in assessing client product and packaging risks and developing options for client consideration.
    • Develop a comprehensive library of standard primary packaging utilized by clients.
    • Support any client packaging qualification activities and collaborating directly with clients or consulting services team members
    • Work with marketing on labeling, branding, instructions, brochures and other marketing materials associated with developed packaging and accessories.
    • Participate and take a leadership role in the Consulting Services packaging and accessory development processes including:
      • Assist in the development of internal Consulting Services packaging and accessory development standards and procedures.
      • Collaborate on packaging and shipper validations/qualifications, lane qualifications/validations and improving our internal workflow, processes, SOPs, templates and ensuring consistency and scalability across clients.
      • Working to always manage and reduce costs, minimize errors and lower Cryoport risk.
      • Ensure projects are delivered on or below budget and at the expected quality and performance.
      • Lead product challenge activities including:
        • Testing product and packaging viability for clients using varied shipping systems focused on cold chain logistics
        • Create purchasing specifications for testing and calibration of equipment.
        • Interact with clients to the extent of understanding challenges, creating solutions to resolve potential impediments to validation success, and deliver on-time per agreed schedules.
        • Keep current with industry standards and regulatory guidelines - especially those around packaging validation and transport of biologic materials. (IATA, ISTA, ASTM, ISO, etc.).
        • Ability to problem solve and find creative solutions to complex Cryoport and client packaging and shipper engineering problems.
        • Proficient math, statistics and data analysis skills including familiarity with Microsoft Office applications and other data analysis and modeling tools.
        • Strong knowledge and hands on experience with polymers, glass, metal, flexible paperboard & corrugated packaging material and manufacturing process, printing and decorating technologies, injection molding, thermoforming and blow molding.
        • Technical knowledge of packaging equipment like form-fill-seal, shrink tunnel, labeler, conveyer systems, etc.
        • Strong communications skills and ability to communicate complicated packaging considerations and designs to clients and internal stakeholders in a clear, meaningful, and concise manner to clients.
        • Demonstrates strong attention to detail and analytical thinking.
        • Ability to manage multiple projects within overlapping timeframes.
        • Team player with ability to manage internal and external teams to achieve deliverables and meet timelines.
        • Proficiency in Office application (Excel, Word, PowerPoint, and Teams) as well as ability to learn project management tools used at Cryoport.
        • High proficiency with 3D modeling and design software (ArtiosCAD, Solidworks, Inventor, etc.)
        • Strongly preferred: Experience with packaging validation and qualification activities across the cold and temperature-controlled supply chain - including shipping systems, packaging (primary, secondary and tertiary), shipping lane qualifications and working experience with internationally accepted standards for package testing and validation (ISTA, IATA, ASTM, etc.)
        • Ability to develop clear presentation and present/interact not only internally at Cryoport but also with clients. Preferred Skills
          • Knowledge and understanding of international Physical and Thermal Performance testing standards, including, but not limited to ISTA, IATA, ISO, and ASTM regulations as it relates to packaging distribution and thermal testing and associated requirements.
          • A comprehensive knowledge and understanding of Thermodynamics.
          • Understanding and experience in:
            • Cold Chain and temperature-sensitive logistics.
            • Packaging testing and qualification.
            • Shipper testing and qualification.
            • (GDP) Good Distribution Practices.
            • USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products.
            • 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs.
            • 21CFR Part 211 cGMP for Finished Pharmaceuticals.
            • Demonstrated analytics ability using large volumes of data in excel and creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics
            • Ability to distill complex data and analysis into protocols, reports and presentations to clients.
            • Demonstrated ability to lead a validation discussion/ validation activity with external clients in a professional manner showing competence and clarity of communication.
            • Experience in developing Validation Activities (supporting Bio-Pharmaceuticals - Cell and Gene Therapies) - with a focus around supply chain, logistics, shipping systems, and packaging. Qualifications and Education Requirements Educational background - B.S./B.A. in Packaging Engineering/Design or related field; M.S or higher preferred.
              Experience background - 6 or more years of multi-material industrial packaging experience preferably in the pharmaceutical/biopharmaceutical industry (or related industry) with preferred 2 or more years' experience directly in pharmaceutical or related cold chain industry.
              • Strong inter-team and client-facing communications experience with the ability to listen and understand client challenges and discuss/communicate design options to help clients clearly understand the various considerations around a specific design so they can make informed decisions.
              • Strong experience with packaging design systems like Inventor, Solidworks (or similar), ArtiosCAD, 3D modeling and design for manufacturing.
              • Experience in Thermal simulations using Inventor and Solidworks.
              • Experience working closely with contract manufacturing, prototyping, and packaging manufacturing.
              • Understanding and expertise in cold chain/temperature sensitive logistics and supply chain.
              • Experience designing packaging for performance and protection of core payload
              • Preferred experience in designing and developing packaging and/or shipping systems for the cold chain
              • Experience designing packaging which performs under industry standard package and shipper qualifications (physical and thermal package testing as well was shipping qualification).
              • Experience directly performing, overseeing and/or collaborating on physical, thermal and shipping qualification of packaging.
              • Knowledge and experience with relevant standards and guidelines including but not limited to: ISTA (thermal and performance testing standards), ASTM (physical performance testing standards), CFR, ISO, PDA, WHO, GxP, etc.
              • Experience building and/or collaborating on validation protocols, executing protocols and building reports for packaging validation/qualification, shipping lane validation, and/or shipping system validation/qualification and testing following industry standards.
              • Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/ Design for Assembly (DFA) tools and methods are desirable.
              • Understanding and/or direct experience with cGMP and FDA validation methodology is desirable.
              • Expected to share examples of professional packaging and/or shipper design and the process to achieve Cryoport -- is a trademark of Cryoport, Inc. and used with permission by Cryoport Systems, LLC

Keywords: Cryoport Systems, Inc., Irvine , Packaging Engineer, Engineering , Irvine, California

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