{"id":479212,"url":"https://alion.io/job/cryoport-validation-engineer","title":"Validation Engineer","company":{"id":5658,"name":"Cryoport","domain":"cryoport.com","url":"https://alion.io/company/cryoport","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0,"time_to_fill_p50_days":51,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":null,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-08-28T00:00:00Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-11-04T02:19:31Z","board_verified":true,"closed_at":null,"days_open":68,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":68},"description":"Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.\nPOSITION SUMMARY:\nThe 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.\nPRIMARY RESPONSIBILITIES (include but are not limited to):\nParticipate and oversee internal Consulting Services qualification processes including:\nAssist in the development of validation procedures.\n\nPerform internal validations including developing validation protocols and reports, preparing equipment, and documenting & analyzing test results.\n\nSupport project creations for shipping lane qualifications, packaging configurations, systemized operational qualifications (physical and/or thermal performance testing), and shipping feasibility studies.\n\nManage qualification activities for Consulting Services’ Consulting Services client related projects.\n\nWork as a team with all Consulting Services team members.\n\nEngage with clients presenting validation plans in client collaboration meetings.\n\nDevelop and customize customer centric quality driven protocols.\n\nAssists with coordination between external third-party testing laboratories to ensure protocol execution, timelines, and quality metrics are achieved.\n\nEvaluate, document, and articulate client specific results utilized strong communication skills.\n\nAssist in optimizing existing protocols, processes, and reporting for all validation activities.\n\n• Engage in continuous process improvement areas within Cryoport Systems Consulting Services\n• Support cross-organizational departments as needed.\nCOMPETENCIES & PERSONAL ATTRIBUTES:\nProfessional with high attention to detail who focuses on client success.\nStrong Communication Skills ñ written and verbal.\nAnalytical thinker with proficient skills in math, statistics, and data analysis applications\nStrong organizational skills to manage multiple projects within overlapping timeframes.\nTeam player with ability to manage internal and external teams to achieve deliverables.\nSelf-motivated with initiative to self-learn to fill in knowledge gaps and expand contributions.\nQUALIFICATIONS AND EDUCATION REQUIREMENTS:\nBA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required)\n2+ years of experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene Therapies is highly preferred)\n2+ Years of Experience in writing professional documentation with customer-facing materials.\nPreferred experience with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain.\nPreferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ.\nKnowledge of cGMP requirements, FDA and ICH guidelines is highly preferred.\nExperience using Excel, creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics.\nProficiency in Microsoft Office (Word, Excel, Power Point, Teams)\nProject Management skills/ training is desirable.\nPREFERRED SKILLS:\nUnderstanding of:\nCold Chain and temperature-sensitive logistics.\n\nPackaging testing and qualification.\n\n(GDP) Good Distribution Practices.\n\nUSP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products.\n\nISO 21973 Biotechnology\n\nGeneral requirements for transportation of cells for therapeutic use.\n\n21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs.\n\n21CFR Part 211 cGMP for Finished Pharmaceuticals.\n\nCompensation: Up to $120,000 depending on experience + bonus, stock, 401k match, benefits, etc.\nCryoport 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).","description_format":"text","description_chars":4732,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Health insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Cold Chain","Pharmaceutical 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