Validation Engineer

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

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.

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.

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.

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.