Senior 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.

Client-facing role within Cryoport Systems Consulting Services department that is responsible for receiving and assimilating client information, assembling requests & requirements, and formulating solutions for new and existing Cryoport Systems clients. The Senior Validation Engineer will focus on client engagement, development of processes and tools to support Consulting Services offerings around shipper / product qualifications as well as other projects primarily supporting biopharmaceutical and cell and gene therapy clients.

Participate and oversee internal Consulting Services qualification/validation processes including:

• Assist in the development of validation standards and procedures.
• Perform internal validations for equipment, new products, and facilities by developing validation protocol & reports, preparing equipment, and documenting & analyzing test results.
• Manage qualification activities for Cryoport Systems’ Consulting Services client related projects.
• Work as a team with all Consulting Services team members.
• Engage with clients by presenting validation plans and participating in client collaboration meetings.
• Develop and customize customer centric quality driven protocols.
• Coordinate and conduct training for qualification activities, requirements, and procedure for all appropriate department stakeholders.
• Execute and monitor client approved protocol with a high degree of oversight ensuring activities, chain of custody, and compliance management are met.
• Assisting 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.
• Serve as a Subject Matter Expert (SME) for the Consulting Validation Engineering group by:
• Ability to quickly access client requests and needs.
• Leading Client facing interactions to better understand challenges, creating solutions, and resolving potential impediments.
• Engage in continuous process improvement areas within Cryoport Systems Consulting Services

Support cross-organizational departments as needed:

• Perform FMEA risk assessment and determine risk mitigation strategies.
• Support Supplier Evaluation and Monitoring program
• Evaluate change control requests for potential for revalidation requirements.
• Provide technical support during non-conforming material, customer complaint, deviation investigations, and assist in the determination of appropriate CAPA, if applicable
• Provide budget requirements and monitor expenses to budget.

• Professional with high attention to detail who focuses on client success.
• Strong Communication Skills – written and verbal.
• Analytical thinker with proficient skills in math, statistics, and data analysis applications
• Strong organizational skills to manage multiple projects within overlapping time frames.
• 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.
• Excellent listening and presentation skills
• Creative thinker and great problem solver

• BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required – advanced degree is a plus)
• 5+ Years of Experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene…