PD Validation Engineer

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

POSITION SUMMARY
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.

PRIMARY RESPONSIBILITIES (included but not limited to)

Validation & Qualification Support
• 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
Product Development, Process & Sustaining Engineering Support
• 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
Cross-Functional & Operational Support
• 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

Documentation & Data Analysis
• 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
Continuous Improvement
• Identify opportunities to improve validation efficiency, standardization, and data quality
• Contribute to departmental initiatives that enhance product reliability, compliance, and performance
 

COMPETENCIES
• 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

QUALIFICATIONS AND EDUCATION 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)

PREFERRED SKILLS
• 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.

Compensation

Up to $140k depending on experience + bonus + stock + benefits + 401k