Senior Packaging Engineer / Packaging Center of Excellence Lead
Company: Cryoport Systems, Inc.
Posted on: January 25, 2023
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 - firstname.lastname@example.org . -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
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,
- 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
- 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,
- 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
- 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
- Troubleshoot new and existing packaging problems involving
designs, materials, and processes and provide creative, timely, and
- 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
- 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
- Ability to problem solve and find creative solutions to complex
Cryoport and client packaging and shipper engineering
- 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
- Ability to manage multiple projects within overlapping
- 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,
- A collaborative team player who embraces and champions the
- 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
- 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
- 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
- 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
- In-depth knowledge of folding carton standard packaging
- In-depth knowledge of corrugate standard packaging
- In-depth knowledge of flexible film standard packaging
- In-depth knowledge of temperature-sensitive standard label
- 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
- Strong experience with packaging design systems like ArtiosCAD,
Inventor, Solidworks (or similar), 3D modeling, and design for
- Experience in Thermal simulations using Inventor and
- 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
- Interact with clients to the extent of understanding
challenges, creating solutions to resolve potential impediments to
validation success, and delivering on time per agreed
- 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
Keywords: Cryoport Systems, Inc., Irvine , Senior Packaging Engineer / Packaging Center of Excellence Lead, Professions , Irvine, California
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