Lead Global Cold-Chain Packaging Engineer

Biogen; North Carolina; On-site; USD 103,000 - 138,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation

Holidays & Time Off

Sick Time

Employee Stock Purchase Plan

Tuition Reimbursement

ERGs

Job summary

Biogen in North Carolina seeks a Logistics Engineer to join the Global Distribution Packaging & Shipping Qualification team. You will lead the design, development, testing, and support of clinical, commercial, and cold-chain distribution packaging across global sites, ensuring GMP-compliant processes and robust distribution strategies.

You will collaborate with Logistics, Quality, and External Manufacturing, manage vendors, draft strategies and study reports, and support audits and regulatory

Qualifications

• BS/BA in Packaging Science/Engineering or related field.
• 5+ years in packaging, global logistics, or temperature-controlled supply chain.
• Experience in an international and regulated environment (cGMP, 21 CFR Part 11) with packaging standards.
• Strong technical writing and MS Office (Word, Excel) proficiency.

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.
• Draft strategies, operational protocols, and supply chain study reports for clinical and commercial programs.
• Develop test strategies for GMP products covering global regulatory requirements.
• Coordinate Supplier Relationship Management meetings and RFPs; manage vendor relationships.
• Oversee lab testing and lane validation to ensure compliance and quality.
• Support audits, inspections, and regulatory inquiries related to shipping qualification.
• Manage Trackwise events, CAPAs, and investigations focusing 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 at internal/external sites including 3PLs.
• Provide training on cold chain practices and regulations across departments.
• Maintain knowledge of cold chain requirements and monitor industry trends.
• Lead weekly cross-functional shipping qualification sub teams and participate in business reviews.
• Develop relationships with customers and partners across Logistics, Quality, and other departments.
• Coach and guide team members, including contractors.

Skills

Packaging

Global Logistics

cGMP Compliance

Temperature Control

Vendor Management

MS Project

PowerPoint

Regulatory Knowledge

Data Analysis

Education

BS in Packaging Science/Engineering

Tools

MS Project

PowerPoint

Job description

Biogen in North Carolina seeks a Logistics Engineer to join the Global Distribution Packaging & Shipping Qualification team. You will lead the design, development, testing, and support of clinical, commercial, and cold-chain distribution packaging across global sites, ensuring GMP-compliant processes and robust distribution strategies.

You will collaborate with Logistics, Quality, and External Manufacturing, manage vendors, draft strategies and study reports, and support audits and regulatory