Validation Engineer

Cryoport, Inc.•Irvine, CA

1d•$120,000

About The Position

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.

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.
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 Haves

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.
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.

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’ 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.