Logistics Engineer, Cold Chain Packaging & Shipping Qualification
BiogenAbout This Role:
As a Logistics Engineer, you will be a pivotal member of the Global Distribution Packaging & Shipping Qualification team. This role is essential in ensuring that Biogen's distribution packaging and cold chain solutions are optimally selected, qualified, and implemented to meet the temperature-controlled supply chain needs.
You will lead and support the design, development, testi
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ng, and support of clinical, commercial, and cold-chain distribution packaging. Your contributions will be vital to the end-to-end supply chain logistics, encompassing all product phases from raw materials to finished goods across global sites. You will work independently to generate scientifically valid data and perform routine analyses, ensuring all work complies with cGMP requirements, SOPs, and test methods.
This role involves collaboration with various departments, including Logistics, Quality, and External Manufacturing, to address business needs and support audits and regulatory inquiries. Your influence and negotiation skills will be key in navigating complex decisions and driving strategic initiatives.
What You’ll Do:
• Lead improvement projects focused on distribution to enhance capabilities and implement new technology.
• Design, develop, and test complex distribution packaging projects from conceptual design through implementation
• Manage external vendors and contribute to the development of distribution packaging standards.
• Draft strategies, operational protocols, and supply chain study reports for clinical and commercial programs.
• Develop test strategy for GMP products that will cover global regulatory requirements
• Participate and facilitate Supplier Relationship Management meetings and RFPs, managing vendor relationships.
• Conduct and oversee lab testing and lane validation activities both internally and externally to ensure compliance and quality standards.
• Support audits, health authority inspections, and regulatory agency inquiries related to shipping qualification
• Manage Trackwise events, CAPAs, and investigations with a focus on compliance and best practices.
• Support Global Change Controls from a SME perspective and manage timelines of activities.
• Provide shipping qualification input on temperature monitoring strategies, tech transfers, and launches.
• Represent the distribution team in cross-functional meetings and provide updates to management. Support technical transfer and launch shipping qualification activities at internal/ external sites and 3PL sites including the shipping, handling, & storage of shipping solutions
• Provide training on cold chain and best practices, guidelines, and regulations across departments including expert advice on the shipping, handling, and storage, and of cold chain solutions.
• Maintain current knowledge of relevant cold chain requirements and monitor emerging industry trends
• Lead weekly cross-functional shipping qualification sub teams and participate in operational/business review meetings.
• Develop and maintain relationships with key customers and partners across various departments such as Logistics, Quality, and other departments to proactively address business needs.
• Coach and provide guidance to team members, including contractors
Who You Are:
You are a detail-oriented engineer with a strong analytical mindset and exceptional problem-solving skills. You are an organized and compliance driven thinker. You thrive in fast-paced environments and have excellent organizational abilities to manage multiple projects simultaneously.
You possess strong communication skills, enabling you to articulate complex recommendations to senior management effectively. As a team player, you excel in cross-functional collaborations and can build robust networks across the company. Your expertise in temperature-controlled logistics, cold chain solutions, and packaging makes you a valuable asset in driving innovative solutions.
Required Skills:
• BS/BA degree required; BS/