Lead Cold-Chain Logistics Engineer

Biogen; Milwaukee (WI); Vor Ort; USD 103.000 - 138.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision, & Life insurr

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Paid vacation and holidays

Parental leave benefit

Zusammenfassung

Biogen is seeking a Logistics Engineer in Milwaukee to join the Global Distribution Packaging & Shipping Qualification team. You will lead design, development, testing, and support of cold-chain distribution packaging for clinical and commercial programs.

In this role you will drive regulatory compliance, manage external vendors, perform lab testing and validation, support audits, and contribute to Trackwise, CAPAs, and change controls while collaborating across Logistics, Quality, and External

Qualifikationen

• 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.
• 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.
• Experience working in a GMP environment is preferred.
• Strong analytical, problem-solving, and communication skills.
• Exceptional team player with project management experience.

Aufgaben

• 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

Kenntnisse

Temperature Controlled Logistics

Cold Chain Solutions

Packaging

Global Logistics

Regulatory compliance

Analytical skills

Problem-solving

Communication skills

Cross-functional collaboration

Project management

Ausbildung

BS/BA in Packaging Science/Engineering

5+ years experience in packaging, global logistics, or temperature-controlled supply chain

Tools

MS Word

MS Project

PowerPoint

Jobbeschreibung

Biogen is seeking a Logistics Engineer in Milwaukee to join the Global Distribution Packaging & Shipping Qualification team. You will lead design, development, testing, and support of cold-chain distribution packaging for clinical and commercial programs.

In this role you will drive regulatory compliance, manage external vendors, perform lab testing and validation, support audits, and contribute to Trackwise, CAPAs, and change controls while collaborating across Logistics, Quality, and External