Cryoport
PD Validation Engineer
Irvine, California, USA
Sponsorship not specifiedDetected 90 days ago
ExpressData AnalysisProduct ManagementProject ManagementExcelSupply ChainLogisticsProcess ImprovementCustomer SupportGMPFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingWritingOrganizational SkillsMicrosoft Office
About the role
- Ensure any/all testing is purpose built and aligned to risk weighted assessment of the intended use and impacts on other teams/processes/products
- Assist in root cause investigations, deviations, and non-conformance activities with data-driven input
- Contribute to continuous improvement of existing products and processes
Responsibilities
- Develop, review, and maintain validation protocols and reports (DQ, IQ, OQ, PQ as applicable)
- Maintain validation standards, templates, and procedures aligned with internal quality systems
- Partner with Product Design, Processing & Sustaining Engineers to assess new products, product changes and determine validation impact
- Collaborate with Quality, Operations, and Supply Chain to ensure compliance and execution of validation activities
- This role also supports the conceptualization, design and development of new ideas and products and associated bench/engineering studies.
- Product Development, Process & Sustaining Engineering Support
- Support engineering change control activities (ECOs, Change Controls, etc.), including evaluation of revalidation requirements
- Cross-Functional & Operational Support
Requirements
- Experience with equipment and process validation (DQ, IQ, OQ, PQ)
- Familiarity with cGMP, FDA, and ICH guidelines
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Experience with statistical data analysis and reporting (e.g., pivot tables, charts)
- Work along side external testing facilities as required- including assisting running experiments at lab sites
- Assist in coordinating external testing, writing protocols & reports when required, ensuring adherence to project scope and timelines
Nice to have
- Bachelor's degree in Engineering, Life Sciences, or related field (advanced degree a plus)
- Experience supporting product lifecycle or sustaining engineering activities preferred
Skills
- Understanding of cold chain, cryogenic systems, or temperature-controlled packaging
- Familiarity with packaging and distribution testing standards (ISTA, ASTM, ISO, IATA)
- Knowledge of Good Distribution Practices (GDP) and related guidelines
- Experience with risk management tools (FMEA, DOE, Lean/Six Sigma methodologies)
- Exposure to supplier qualification and manufacturing environments
- Project coordination or project management experience
Compensation
- Up to $140k depending on experience + bonus + stock + benefits + 401k
Benefits
- Up to $140k depending on experience + bonus + stock + benefits + 401k
Company info
- Follow company approved document QMS
- This role is part of the Product Development organization and supports Product Design (Shipping Systems, Packaging, Accessories), Process Engineering, Sustaining Engineering and cross-functional teams in maintaining, validating, and
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This listing is sourced directly from Cryoport's careers page and normalized into a canonical job model.