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Role Summary
Responsibilities
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance.
- Execute tasks as defined in internal guiding documents, including SOPs and work instructions.
- Apply Good Documentation Practices (GDP) and Data Integrity requirements to maintain accurate and compliant records for audits and inspections.
- Complete assigned training in line with required learning plans and requalification cadences.
- Analyze logistics systems and design improvements to enhance efficiency, reduce costs, and improve supply chain performance.
- Identify process bottlenecks and propose practical, sustainable solutions.
- Collect and analyze logistics and transportation data to support ongoing projects.
- Participate in logistics projects from initiation through implementation, including collaborations with 3PLs and carriers.
- Evaluate and recommend technology and digital solutions (automation, analytics, temperature monitoring tools) to strengthen supply chain operations.
- Ensure logistics solutions and innovations comply with relevant safety and regulatory standards.
- Prepare reports and presentations highlighting findings, recommendations, and impacts of implemented solutions related to Quality Management Systems and cold chain requirements.
- Support shipping validation activities, including Operational and Performance Qualification (OQ/PQ) for active and passive shippers.
- Assist in developing training materials and supporting knowledge transfer for new shipper solutions or process rollouts.
Qualifications
- Current student enrolled in a Bachelorโรรดs or master's program in Chemical Engineering, Mechanical Engineering, Supply Chain Management, or a related field.
- Strong foundation in scientific and engineering principles, with preference for knowledge in thermodynamics and heat transfer.
- Demonstrated ability to learn and apply GxP regulations (GMP, GLP, GCP, GVP, or others as applicable).
- Strong communication skills, including technical writing and presentation abilities.
- Analytical mindset with the ability to evaluate data and identify process improvements.
- Ability to collaborate effectively in cross-functional and global team settings.
- Must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
- This position is site-based, requiring you to be at Modernaโรรดs site full-time. This position is not eligible for remote work.
Skills
- GxP regulatory knowledge
- Data analysis
- Project coordination
- Technical writing and presentation
- Cross-functional collaboration
Education
- Relevant degree programs as listed in Qualifications
Additional Requirements