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Cryoport, Inc.

Validation Engineer

Salary$120k
LocationIrvine, California
Typefull-time
SeniorityMid
Experience2+ yrs
DepartmentConsulting Services
EquityIncluded
Company size25+ people
PostedAug 28, 2026 · 1mo ago
Verified live1h ago
At a glanceSummarised by Seekless from the posting.
Must have5
BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required)
2+ years of experience in Biopharmaceuticals, Medical Device Industry
2+ Years of Experience in writing professional documentation with customer-facing materials
Experience using Excel, creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics
Proficiency in Microsoft Office (Word, Excel, Power Point, Teams)
Nice to have5
Experience specifically in Cell & Gene Therapies
Preferred experience with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain
Preferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ
Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred
Project Management skills/ training is desirable
Skills
Excel
Microsoft Word
Microsoft Power Point
Microsoft Teams
Benefits
Health insurance
401(k)
Stock
About the company
Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.
About the role
POSITION SUMMARY:
The Validation Engineer - Consulting Services will support the Consulting Services team’s offerings around shipper, packaging, and shipping lane qualifications across temperature sensitive supply chains. This is a client-facing role within the Cryoport Systems Consulting Services department that is responsible for engaging in client discussions, performing qualifications, and developing technical reports.
Responsibilities
PRIMARY RESPONSIBILITIES (include but are not limited to):
• Participate and oversee internal Consulting Services qualification processes including:
•
Assist in the development of validation procedures.
•
Perform internal validations including developing validation protocols and reports, preparing equipment, and documenting & analyzing test results.
•
Support project creations for shipping lane qualifications, packaging configurations, systemized operational qualifications (physical and/or thermal performance testing), and shipping feasibility studies.
•
Manage qualification activities for Consulting Services’ Consulting Services client related projects.
•
Work as a team with all Consulting Services team members.
•
Engage with clients presenting validation plans in client collaboration meetings.
•
Develop and customize customer centric quality driven protocols.
•
Assists with coordination between external third-party testing laboratories to ensure protocol execution, timelines, and quality metrics are achieved.
•
Evaluate, document, and articulate client specific results utilized strong communication skills.
•
Assist in optimizing existing protocols, processes, and reporting for all validation activities.
•
• Engage in continuous process improvement areas within Cryoport Systems Consulting Services
•
• Support cross-organizational departments as needed.
COMPETENCIES & PERSONAL ATTRIBUTES:
• Professional with high attention to detail who focuses on client success.
• Strong Communication Skills ñ written and verbal.
• Analytical thinker with proficient skills in math, statistics, and data analysis applications
• Strong organizational skills to manage multiple projects within overlapping timeframes.
• Team player with ability to manage internal and external teams to achieve deliverables.
• Self-motivated with initiative to self-learn to fill in knowledge gaps and expand contributions.
Requirements
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
• BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required)
• 2+ years of experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene Therapies is highly preferred)
• 2+ Years of Experience in writing professional documentation with customer-facing materials.
• Preferred experience with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain.
• Preferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ.
• Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred.
• Experience using Excel, creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics.
• Proficiency in Microsoft Office (Word, Excel, Power Point, Teams)
• Project Management skills/ training is desirable.
Nice to have
PREFERRED SKILLS:
• Understanding of:
•
Cold Chain and temperature-sensitive logistics.
•
Packaging testing and qualification.
•
(GDP) Good Distribution Practices.
•
USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products.
•
ISO 21973 Biotechnology
•
General requirements for transportation of cells for therapeutic use.
•
21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs.
•
21CFR Part 211 cGMP for Finished Pharmaceuticals.
Benefits
Compensation: Up to $120,000 depending on experience + bonus, stock, 401k match, benefits, etc.
Legal
Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).
More roles at Cryoport, Inc.
Team Lead - KittingSenior Manufacturing EngineerDirector- Consulting ServicesCost Accounting Manager (Contingent)Corporate Paralegal
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