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Validation / Quality Engineer Position Summary

If you’re interested in joining our team, please send your resume and cover letter to hr@cryoport.com. Make sure to include the job title of the position you are interested in the subject line of your email. 

Job Title: Validation / Quality Engineer 
Job Category: Staff
Department/Group: Engineering
FLSA Status: Exempt
Reports To: VP - Quality Assurance and Regulatory Affairs
Travel Required: Up to 30%

Position Summary
Responsible for supporting all validation/qualification activities including new and existing products, process validation and equipment qualification.  Ensures Calibration Program operates in compliance with current specifications and requirements to ensure the production of quality products.  Supports investigations and change control program as a subject matter expert.

Role and Responsibilities:

  • Manage the validation process including:
    • Assist in the development of internal validation standards and procedures.
    • Perform internal validations for equipment, new products and facilities including developing validation protocols and reports, preparing equipment, documenting test results.
    • Manage validation activities for consulting related projects for product and lane validations.
    • Coordinate validation activities with appropriate department stakeholders and train staff on requirements and procedures.
    • Develop master validation plan and track validation activities.
  • Manage testing and product related equipment including:
    • Create purchasing specifications for testing and calibration of equipment
    • Oversee the equipment calibration program including scheduling and tracking calibration requirements, evaluating calibration results, developing calibration procedures and managing communication with external calibration vendors
    • Provide budget requirements and monitor expenses to budget
  • Support the New Product Development Process including:
    • Perform FMEA risk assessment and determine risk mitigation strategies.
    • Assist in the development of process related documentation
  • Support Supplier Evaluation and Monitoring program
    • Assist with selection of supplier by performing on-site technical audits
    • Evaluate supplier product and process information to determine approval status
  • Evaluate change control requests for potential for revalidation requirements.
  • Provide technical support during non-conforming material, customer complaint and deviation investigations and assist in the determination of appropriate CAPA.
  • Keep current with industry standards and regulatory guidelines


  • Ability to problem solve and find creative solutions to complex engineering problems.
  • Proficient math, statistics and data analysis skills including familiarity with Microsoft Office applications, EDMS, and calibration management tools.
  • Demonstrates strong attention to detail and analytical thinking.
  • Ability to manage multiple projects within overlapping timeframes.

Qualifications and Education Requirements:
Educational background – B.S. in Engineering, Packaging, or a related scientific field.

Experience background - 5 or more years of experience in the pharmaceutical, biotech or medical device industry and/or relevant experience in packaging design, heat transfer, cryogenics with knowledge of:

  • Equipment and Process Validation using IQ, OQ, and PQ.
  • Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM) / Design for Assembly (DFA) tools and methods.
  • Cleaning validation, cGMP and FDA validation methodology is desirable.

Preferred Skills:
Understanding of:

    •  Cold Chain logistics,
    • (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.


What our clients are saying

“I contacted Cryoport to transport stem cells from Denver, Colorado, to Albuquerque, New Mexico, and the service provided was excellent. It was a hassle-free transport. I was especially impressed with the continuous communication throughout the transport and particularly appreciated the fact that not only did my shipment arrive in good condition, but Cryoport also made all of the arrangements for the return of the shipper so that I didn’t have to. Our facility will definitely use Cryoport’s service in the future and would recommend it to others.”
Stem Cell Transplant Coordinator – Cryoport Customer
“Cryoport does an amazing job of handling the shipping and logistics for transporting cryopreserved materials. We have switched to them for all of our exports.”
Bioengineering Core Employee – Cryoport Customer
“As a customer I'm very pleased with the service I received from Cryoport. Cryoport’s team always answered my questions, provided help in a professional manner and were extremely attentive.”
Cryoport Customer
“Had I known how great Cryoport’s dry vapor shipper and logistics system worked, we would have used Cryoport for all our previous shipments to the U.S. In the past we have used dry ice and several times we lost valuable cells because our shipments would sit in customs forever and the dry ice would evaporate. Cryoport eliminated that concern altogether. I will certainly be utilizing Cryoport’s services for future shipments.”
Principal Investigator – Cryoport Customer
“By using Cryoport I experienced much less stress as my shipment went through customs!”
Principal Investigator – Cryoport Customer
“I called Cryoport after hours for information about a shipment I needed to schedule and received absolutely outstanding customer service. Cryoport provided me with a lot of helpful information and great advice. It's rare and refreshing to receive such great service.”
Cryoport Customer
“Not only did my cells arrive safely, Cryoport’s service was professional and efficient. I highly recommend Cryoport.” 
Hematologist – Cryoport Customer

“Working with Cryoport was a truly remarkable difference compared to my experience with other shippers. With the previous shipping company I was working with, it took almost three months to establish a ‘deep frozen account’ and required numerous hoop-jumping shenanigans only to ultimately be informed that the company could not arrange a shipment to or from Israel, which they were informed from the start was our desired shipping source.

Our sales rep at this organization was as dumbfounded by our experience as we were. To his credit, after his company declined our business, he suggested I contact Cryoport. I have written thanking him for his suggestion and to let his ‘powers-that-be’ know how different my experiences were.”

Cryoport Biopharma Customer
“When compared to other shippers, I am highly satisfied with Cryoport’s pricing and service.”
Lab Manager – Cryoport Customer
“Our organization is more than impressed by our experience with Cryoport. We feel confident our material is being well-managed throughout transit. Cryoport provides extraordinary customer service and continuously they not only meet, but exceed our expectations. Late yesterday afternoon Cryoport worked tirelessly to coordinate a shipment to Japan and today seemed to effortlessly manage a late-day return. It is a pleasure working with Cryoport.”
Senior Supply Chain Analyst – Cryoport Customer
“Cryoport’s service is easy, straightforward and very convenient. We used to run into issues with transporting specimens to outside labs and Cryoport has eliminated this hurdle. Knowing Cryoport has it handled helps me sleep at night.”
Professor of Anatomy, Histology and Cell Biology – Cryoport Customer
“I'd like to commend Cryoport for their fantastic service. Our collaborator was also similarly impressed and will be recommending Cryoport to her colleagues. In addition to the great service and quality product, Cryoport’s pricing is second to none. We look forward to working with Cryoport for all of our future temperature-sensitive shipments."
Lab Manager – Cryoport Customer

"I want to thank everyone at Cryoport who was involved in the rapid recovery of the missing Cryoport shipper containing a patient’s tumor tissue. By promptly locating the shipper and recharging it while in transit, the patient was able to receive the vaccine manufactured from this tissue on time. We are so very appreciative of Cryoport’s customer service. Without the services that Cryoport provides, our clinical trials would not be available to patients."

Director of Clinical Operations — Cryoport Customer
“Cryoport provides a reliable solution to ship temperature-sensitive biologics around the world. The Cryoport solution is easy for scientists to use. They respond quickly, have great customer service and anticipate problems. I am able to speak to someone 24/7 who is an expert on MY package. It is personal service focused on deep frozen life sciences. I consider Cryoport to be an extended member of my team.”
Product Operations Specialist – Cryoport Customer