Overview
In this role you will lead and support the design, testing, and qualification of distribution packaging and cold chain solutions across global sites. You’ll collaborate with Logistics, Quality, and partners to ensure compliant, efficient temperature-controlled shipping for clinical and commercial programs. Your work drives robust packaging strategies, rigorous testing, and continuous improvement in a cGMP context. This is an opportunity to shape global logistics capabilities and enable reliable supply of life-changing medicines.
Verantwortungsbereiche
- Lead complex distribution packaging improvement projects to boost capabilities and efficiency
- Develop and test end-to-end distribution packaging solutions from design to implementation
- Create test strategies for GMP products covering global regulatory requirements
- Facilitate supplier relationship management meetings and RFPs to manage vendor relationships
- Collaborate with Logistics, Quality, and other functions to address business needs
- Oversee lab testing and lane validation to ensure compliance and quality standards
- Support audits, health authority inspections, and regulatory inquiries related to shipping qualification
- Manage Trackwise events, CAPAs, and investigations with a compliance focus
- Support global Change Controls from SME perspective and manage activity timelines
- Provide input on temperature monitoring strategies, tech transfers, and launches
- Represent the distribution team in cross-functional meetings and report to management
- Support shipping qualification activities at internal, external, and 3PL sites including handling and storage of shipping solutions
- Provide training on cold chain, guidelines, and regulations across departments
- Maintain current knowledge of cold chain requirements and monitor industry trends
- Coach and mentor team members and contractors
Zentrale Anforderungen
- BS/BA degree
- At least 5 years in packaging, global logistics, or temperature-controlled supply chain
- Experience in international regulated environments with knowledge of ASTM/ISTA packaging standards
- Experience in testing standards and distribution lab environments
- Strong analytical, problem-solving, and communication skills
- Excellent team player with project management experience
- Expertise in Temperature Controlled/Cold Chain Logistics, Transportation, and Packaging
- US Domestic and International experience
- Strong technical writing and Microsoft Word skills
- Ability to present to cross-functional teams with clear updates
- GMP experience
- Experience with Failure mode analysis (Ishikawa, 5 Why)
- organized
- analytical
- compliance-driven
- Temperature Controlled/Cold Chain Logistics
- Packaging design and testing
- GMP regulatory knowledge
Logistics Engineer in Baar Arbeitgeber: Biogen Idec
Biogen ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einer dynamischen und innovativen Umgebung zu arbeiten, während Sie die globale Omnichannel-Transformation im Bereich Kundenengagement leiten. Unsere Unternehmenskultur fördert Zusammenarbeit und kontinuierliches Lernen, unterstützt durch umfassende Programme zur Mitarbeiterentwicklung und strategische Initiativen, die darauf abzielen, die Kundenbindung zu verbessern. Darüber hinaus profitieren Sie von einem flexiblen Arbeitsumfeld und der Chance, an vorderster Front der digitalen Transformation in der Biotechnologiebranche zu stehen.
