PD Validation Engineer

Cryoport Systems•Irvine, CA

17h

About The Position

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 improving Cryoport's existing products, processes, and systems. This role also supports the conceptualization, design and development of new ideas and products and associated bench/engineering studies. The Validation Engineer is responsible for executing and supporting product design testing, internal qualification and validation activities for products, equipment, and processes. This position focuses on ensuring product reliability, compliance, and performance through structured validation practices, while also contributing to continuous improvement initiatives across the department.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field (advanced degree a plus)
5 - 10+ years of experience in validation, quality, or engineering within pharma, biopharma, medical device, or related industries
Experience with equipment and process validation (DQ, IQ, OQ, PQ)
Familiarity with cGMP, FDA, and ICH guidelines
Experience supporting product lifecycle or sustaining engineering activities preferred
Strong technical writing and documentation experience
Proficiency in Microsoft Office (Excel, Word, PowerPoint)
Experience with statistical data analysis and reporting (e.g., pivot tables, charts)
Strong attention to detail with a focus on quality and compliance
Effective written and verbal communication skills
Analytical mindset with proficiency in data analysis and problem-solving
Strong organizational skills with ability to manage multiple priorities
Collaborative team player across engineering and operational functions
Self-motivated with a continuous learning mindset
Practical, solutions-oriented approach to technical challenges

Nice To Haves

Understanding of cold chain, cryogenic systems, or temperature-controlled packaging
Strong understanding and experience with product development qualification/validation activities (logistics, pharmaceuticals, medical devices, etc.)
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
Knowledge / Understanding of: 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

Support and execute internal bench testing, studies, qualification and validation activities for existing products, equipment, and processes - in collaboration with Design, Packaging and Process Engineering
Develop, review, and maintain validation protocols and reports (DQ, IQ, OQ, PQ as applicable)
Prepare test setups, execute validation activities, and document/analyze results
Maintain validation standards, templates, and procedures aligned with internal quality systems
Work along side external testing facilities as required- including assisting running experiments at lab sites
Partner with Product Design, Processing & Sustaining Engineers to assess new products, product changes and determine validation impact
Ensure any/all testing is purpose built and aligned to risk weighted assessment of the intended use and impacts on other teams/processes/products
Support engineering change control activities (ECO’s, Change Controls, etc.), including evaluation of revalidation requirements
Assist in root cause investigations, deviations, and non-conformance activities with data-driven input
Contribute to continuous improvement of existing products and processes
Collaborate with Quality, Operations, and Supply Chain to ensure compliance and execution of validation activities
Support supplier-related validation or qualification activities as needed
Assist in coordinating external testing, writing protocols & reports when required, ensuring adherence to project scope and timelines
Provide technical input for CAPA, risk assessments (FMEA), and process improvements
Generate clear, concise validation documentation, reports, and technical summaries
Analyze test data and communicate results effectively to internal stakeholders
Support development and improvement of validation processes, tools, and reporting methods
Follow internal document writing standards and procedures.
Follow company approved document QMS
Identify opportunities to improve validation efficiency, standardization, and data quality
Contribute to departmental initiatives that enhance product reliability, compliance, and performance