Senior Packaging Engineer / Packaging Center of Excellence Lead

Company: Cryoport Systems, Inc.
Location: Irvine
Posted on: January 25, 2023

Job Description:

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

Job Title: Senior Packaging Engineer / Packaging Center of Excellence Lead
Job Category: Staff
Department/Group: Consulting Services
FLSA Status: -Exempt
Reports To: Global VP of Consulting Services
Travel Required: Up to 15% Position Summary
Client-facing Senior Packaging Engineer will directly interact 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. The 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 designing, developing, and executing 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 sheets, other polymers (thermoformed, blown, injection-molded, rotomolded), coated chipboard materials (for flat pack and rigid cryoboxes, kits, etc.), and 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. 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 with high proficiency in designing packaging solutions based on client needs, shipper and temperature constraints and focusing on a delightful user experience using industry standard tools like ArtiosCAD w/ CAPE, Solidworks, AutoCAD. Responsibilities include but are not limited to:

• Design, develop, prototype, manage the manufacturing of innovative cold-chain packaging and accessory solutions
• Knowledge of the various suppliers and cold chain solutions available to support FDA regulated industry
• Rapidly develop client and Cryoport solutions using industry-standard software tools like ArtiosCAD, Inventor, Solidworks
• Ability to manage in a fast-paced, client-focused environment with multiple simultaneous projects, short deadlines, changing priorities, changing timelines, and client needs.
• 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 to create innovative packaging solutions
• Drive, motivation, and commitment to excellence 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 focus on delivering cost-effective and timely solutions - and understanding how to balance these items
• 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, pack-out/load, handling, monitoring, unload, and distribution.
• Communicate with clients and understand client solution needs (and project constraints - budget, size, features, etc) and provide an 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 / 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, cost-effectively, and efficiently.
• Develop optimized packaging manufacturing, handling, conditioning, loading, and unloading processes.
• Lead the Cryoport Packaging Center of Excellence and be responsible for developing 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 solutions
• Support label design and development needs by clients across Cryoport and BioServices.
• Oversee and manage the complete packaging development process, including the creation of packaging designs (including design for manufacturing), prototype development, and performance testing.
• Troubleshoot new and existing packaging problems involving designs, materials, and processes and provide creative, timely, and cost-effective solutions.
• 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 and associated materials to help clients understand the materials, trade-offs and considerations (price, performance, manufacturing constraints, etc.)
• Support any client packaging qualification activities and collaborate 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
  • 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, conveyor systems, etc.
  • 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 the ability to manage internal and external teams to achieve deliverables and meet timelines.
  • High proficiency with 3D modeling and design software (ArtiosCAD, Solidworks, Inventor, etc.)
  • Ability to develop clear presentation and present/interact internally at Cryoport and with clients.
  • Strong inter-team and client-facing communications skills 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.
  • A solid understanding of Thermodynamics, -Thermal transfer and heat transfer with a focus on ultra-cold temperatures
  • Understanding and expertise in cold chain/temperature-sensitive logistics and supply chain.
  • Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/ Design for Assembly (DFA) tools and methods are desirable.
  • 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.)
  • Passion for, and alignment with, Cryoport's mission
  • A change agent and strong collaborator who is not afraid of challenging the status quo
  • An individual who brings strong core values, quality, ethics, and integrity
  • A collaborative team player who embraces and champions the culture
  • Strong work ethic and ability to deliver results and meet commitments in a dynamic environment
  • Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture
  • Exceptional organizational and planning skills, strong analytical abilities, and process orientation
  • Demonstrates a business process orientation to developing solutions
  • leverage the various industry solutions offered by various suppliers specialize in cold supply chain offering and configure their solutions to fit the internal demand of our client requirements 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 on supply chain, logistics, shipping systems, and packaging.Qualifications and Experience directly performing, overseeing, and/or collaborating on physical, thermal, and shipping qualifications 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 (will be working with Cryoport Consulting Services Validation Engineering team on any qualifications).
        • Understanding and/or direct experience with cGMP and FDA validation methodology is a plus.
        • Help manage external test facilities and provide direct oversight and guidance for testing including planning, procurement, and organization of test materials
        • Author technical documentation related to packaging for design requirements, design verification, technology transfer, qualification or validation protocols and reports, and assessments based on comparability, manufacturability, suitability, and risks
        • Support documentation management for global standards and policies as well as standard operating procedures, test methods, work instructions, specifications, and drawings
        • Assume responsibilities for all necessary quality systems for change controls related to packaging as well as vendor change notifications, complaints, deviations, and CAPAs
        • Knowledge of all aspects of the Cold Chain and International Transportation, including expertise in cGMP Education Requirements
          • S./B.A. in Packaging Engineering/Design or related field; M.S or higher preferred.
            • Highly prefer a graduate of an accredited packaging degree (design/materials/science) program
            • In-depth knowledge of folding carton standard packaging materials
            • In-depth knowledge of corrugate standard packaging materials
            • In-depth knowledge of flexible film standard packaging material
            • In-depth knowledge of temperature-sensitive standard label material
            • 10+ years packaging related experience
            • 6 or more years of multi-material industrial packaging experience preferably in the pharma/biopharma industry (or related industry) with preferably
            • 2+ yrs. exp directly in the pharmaceutical or related cold chain industry.
            • Strong experience with packaging design systems like ArtiosCAD, Inventor, Solidworks (or similar), 3D modeling, and design for manufacturing.
            • Experience in Thermal simulations using Inventor and Solidworks.
            • Experience working closely with contract manufacturing, prototyping, and packaging manufacturing.
            • 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).
              • our internal workflow, processes, SOPs, templates, and consistency and scalability across clients.
              • Working to always manage and reduce costs, minimize errors, and lower Cryoport risk.
              • Establish standards and guidelines for supplier evaluation
              • Evalu ate and select packaging suppliers/vendors; periodically conduct vendor reviews.
              • 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 delivering on time per agreed schedules.
                • Keep current with industry standards and regulatory guidelines - especially those around packaging validation and transport of biological materials. (IATA, ISTA, ASTM, ISO, etc.). Cryoport - is a trademark of Cryoport, Inc. and used with permission by Cryoport Systems, LLC

Keywords: Cryoport Systems, Inc., Irvine , Senior Packaging Engineer / Packaging Center of Excellence Lead, Professions , Irvine, California