Senior Specialist, Logistics Engineering

Role Summary

Senior Specialist, Logistics Engineering will lead Moderna's international cold chain logistics and shipping validation programs. You will own the design and deployment of distribution procedures, act as a subject matter expert across functions, and oversee global shipping systems. You will author regulatory-compliant SOPs and advise on complex cold chain issues, integrating technologies like IoT analytics and digital twins to improve visibility and compliance. This role is based in Madrid and contributes to Moderna's global distribution capability.

Responsibilities

• Oversee the global implementation of Moderna’s International Logistics Engineering program, including strategies, milestones, and compliance with cold chain requirements.
• Act as owner and subject matter expert for Moderna’s global shipping systems and methods, actively contributing as a core member of the Cold Chain and Shipping Validation teams.
• Lead projects related to logistics visibility, such as real-time tracking, temperature control, digital twins, and IoT analytics.
• Author and manage critical documentation, including SOPs, work instructions, and policies related to Cold Chain and global distribution.
• Partner with internal teams (Manufacturing, Distribution/Logistics, Quality) and external stakeholders to support and implement shipping systems across the International organization.
• Train teams across functions on cold chain regulations, best practices, and guidelines to embed compliance culture across the organization.
• Support the distribution-related technical transfer activities at CMO and 3PL sites.
• Provide guidance during GMP/GDP audits and regulatory inspections concerning cold chain and logistics engineering.
• Monitor, assess, and develop controls to ensure compliance with cold chain handling, storage, and shipping across the supply chain.
• Qualify and collaborate with external vendors such as Freight Forwarders and Carriers, contributing to SOP development, Quality Agreements, and Statements of Work.
• Stay abreast of evolving cold chain regulations and trends, ensuring Moderna’s guidelines remain best-in-class and fully compliant.
• Support internal investigations and drive corrective actions related to any non-conformities in cold chain operations.
• Report key performance indicators (KPIs) and risk metrics to senior leadership to drive continuous improvement in cold chain performance.
• Perform additional duties as required in alignment with evolving business and compliance needs.

Qualifications

• Required: University degree in technology, engineering, or related field.
• Required: 4–6 years (BA/BS) or 2–4 years (MS) in Cold Chain, Supply Chain, Manufacturing & Science, and Logistics functions; strong preference for pharmaceutical/biotech experience and experience in a cGMP environment.
• Preferred: APICS CSCP or CLTD certification.
• Preferred: Experience with project management, risk management methodologies, and monitoring techniques.
• Preferred: Experience with IoT devices, digital twins, and AI tools and their application.
• Preferred: Experience with managing Quality System events (Change Controls, CAPAs, Deviations, etc.).
• Preferred: Experience with creating GMP Documentation (SOPs, Work Instructions, Policies, etc.).
• Preferred: Knowledge of cold chain technology, tools, and shipping qualification.
• Preferred: Other government agency regulatory experience relating to biotech manufacturing.
• Preferred: Outstanding communication skills (verbal and written) to collaborate with senior management in a dynamic, cross-functional matrix environment.
• Preferred: Well organized; strong written and verbal communication; ability to structure complex information clearly.
• Preferred: Results-driven with a track record of delivering in fast-paced environments.
• Preferred: Strong PowerPoint skills to visualize complex content.
• Preferred: Curiosity and willingness to challenge the status quo.
• Preferred: Desire to contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Education

• University degree in technology, engineering, or related field.