Logistics Engineer

Biogen•Research Triangle Park, NC

About The Position

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, testing, 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.

Requirements

BS/BA degree required; BS/BA in Packaging Science/Engineering preferred.
At least 5 years of experience in packaging, global logistics, or temperature-controlled supply chain.
Experience in an international and regulated environment (cGMP, cGDP, 21 CFR Part 11, ANVISA, Health Canada) with knowledge of packaging standards (ASTM/ISTA) and regulations.
Expertise in Temperature Controlled/Cold Chain Logistics, Transportation, and Packaging.
Experience in testing standards and distribution lab environment
US Domestic and International experience required.
Strong technical writing skills and strong microsoft word knowledge.
Proficiency in MS Project and PowerPoint.
Ability to present to cross-functional teams and provide succinct clear updates and information
Ability to develop rapport at various organizational levels.
Strong analytical, problem-solving, and communication skills.
Exceptional team player with project management experience.

Nice To Haves

Lean Six Sigma/Green Belt certification is an asset.
Experience with MS Project and PowerPoint.
Ability to develop rapport at various organizational levels.
Experience working in a GMP environment is preferred.

Responsibilities

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

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation