Senior Cold Chain Engineer

Aurion Biotech is a clinical-stage biotech company focused on restoring vision through regenerative therapies. They are seeking a Senior Cold Chain Engineer to design, implement, and optimize temperature-controlled supply chain systems for research and clinical operations, ensuring compliance and operational readiness.

Responsibilities:

• Design, qualify, and optimize LN2, cryogenic, frozen, refrigerated, and CRT cold chain systems across internal and external networks
• Lead the selection, qualification, and lifecycle management of: LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
• Define temperature excursion tolerances, hold times, and stability-aligned packaging strategies
• Build cold chain capabilities to support R&D, clinical trials, and future commercial scale
• Develop and execute cold chain strategies aligned with Long-term storage requirements and global distribution and site variability
• Serve as the cold chain SME during process development, tech transfer, and scale-up initiatives
• Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities
• Author and review validation protocols, reports, and technical assessments
• Conduct failure mode and risk analyses for cold chain processes and shipping lanes
• Design and implement mitigation strategies for LN2 and CO2 supply interruptions, equipment failures, and transit risks
• Ensure cold chain operations comply with GxP, and internal quality standards
• Partner with Quality to develop and maintain: SOPs, work instructions, and deviation response playbooks
• Temperature excursion investigation frameworks
• Support audits, inspections, and regulatory readiness activities related to cold chain operations
• Act as the technical lead for cold chain vendors, couriers, and logistics providers
• Evaluate vendor capabilities, lead technical due diligence, and support contracting decisions
• Drive continuous improvement through performance reviews, root-cause investigations, and CAPAs in alignment with Quality
• Define KPIs and dashboards for cold chain performance (excursions, lane reliability, cost, recovery time)
• Leverage temperature data, shipment analytics, and trend analysis to proactively improve system robustness
• Champion standardization and best-practice adoption across programs and geographies
• Serve as the cold chain subject-matter expert across Supply Chain, Manufacturing, Quality, Clinical Ops, Commercial Ops, and R&D
• Translate scientific, regulatory, and operational needs into executable cold chain solutions
• Independently identify gaps, propose solutions, and drive projects from concept through implementation
• Performs other duties as assigned

Requirements:

• Bachelor's degree in engineering, supply chain, life sciences, or related technical field
• 7–12+ years of experience in cold chain engineering, logistics, or operations within biotech, pharma, cell/gene therapy, or biologics
• Hands-on experience with LN2 and cryogenic cold chains (storage, shipping, and monitoring) with biologics
• Proven track record of owning complex technical projects end-to-end with minimal oversight and ability to operate independently
• Direct experience with packaging qualification, lane validation, and temperature excursion management
• Proficiency in Microsoft Office Suite, DocuSign, and Smartsheet
• Master's degree in engineering, supply chain, life sciences, or related technical field
• Relevant certifications a plus: Cold Chain or GDP certifications
• Six Sigma / Lean methodologies