Cryoport

Cryoport

Validation Engineer

Irvine, California

Sponsorship not specifiedDetected 30 days ago
ExpressData AnalysisStatisticsProject ManagementExcelSupply ChainLogisticsProcess ImprovementCustomer SupportLoad TestingGMPFDA RegulatoryMedical DevicesCommunicationCollaborationPublic SpeakingOrganizational SkillsMicrosoft Office

About the role

  • PRIMARY RESPONSIBILITIES (include but are not limited to):
  • Participate and oversee internal Consulting Services qualification processes including:
  • Assist in the development of validation procedures.

Responsibilities

  • 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.
  • Develop and customize customer centric quality driven protocols.
  • Evaluate, document, and articulate client specific results utilized strong communication skills.
  • Support cross-organizational departments as needed.

Requirements

  • 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 have

  • 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.

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.
  • Strong Communication Skills ñ written and verbal.
  • Analytical thinker with proficient skills in math, statistics, and data analysis applications

Compensation

  • Up to $120,000 depending on experience + bonus, stock, 401k match, benefits, etc.

Equal opportunity

  • 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).
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This listing is sourced directly from Cryoport's careers page and normalized into a canonical job model.