Validation Engineer

About the role

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 responsible for engaging in client discussions, performing qualifications, and developing technical reports.

Responsibilities

• 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’ 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.
• Assist 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 utilizing 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.

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, PowerPoint, Teams).
• Project Management skills/training is desirable.

Skills

• 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 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.
• 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.

Pay

Up to $120,000 depending on experience, plus bonus and stock.

Benefits

• Health insurance
• 401K with company match and stock equity (Nasdaq: CYRX)