
Principal Packaging Engineer, CAR-T
- Beerse, Antwerpen
- Vast
- Voltijds
- Provide specialized support for CAR-T secondary & tertiary packaging, including packaging engineering support for new product launches, technical transfers and lifecycle management related activities, for CAR-T Belgium manufacturing sites.
- Apply strong technical expertise in secondary and tertiary packaging material design, equipment, technical artwork and transportation qualification (physical protection)
- Work closely with MSAT colleagues (Technical Launch Integrators, Technical Owners, Site MSAT teams etc), Manufacturing Sites, Product Artwork, Quality, Value Chain Management, Product Artwork, Global Planning & Reg. Demand & Supply, Global Brand Protection, Distribution Center
- Drive/support technical projects in a complex J&J/Legend environment
- Drive scouting and evaluation of new packaging technology, designs and standards, and integrate those to optimize packaging operations, reduce cost of goods and reduce our environmental footprint.
- Cross-regional coordination to ensure standardization and innovation across US & Belgum CAR-T manufacturing sites
- Partner internally and benchmark externally to leverage and integrate best practices
- ·Demonstrated project management and business acumen capabilities
- Minimum of a Bachelor’s / University degree in Engineering is required.
- Degree or equivalent experience in Packaging Engineering is preferred.
- Minimum of 10 years of relevant experience in a Pharmaceutical / regulated environment including packaging manufacturing and/or support environment
- Proven experience in packaging equipment, packaging material & transportation related qualification activities.
- Supply Chain experience, including expertise in value chain, manufacturing, external vendor management, and/or related areas
- Experience with guides and regulations as well as industry technical standards relative to Packaging including experience with international and pharmaceutical regulatory authorities. Knowledge & expertise in applying cGMP regulations (e.g., FDA, GMP, ICH, etc.).
- High intellectual curiosity to challenge the status quo and learn artwork processes and how they relate to other supply chain processes as well as impact on the customer experience
- The ability to multi-task, work with minimal direction, and demonstrate resiliency and high productivity with constraints of schedule and budget
- Strong interpersonal skills, team player, influencing without authority, setting priorities and strong demonstrated stakeholder management
- Strong cross-functional supply chain acumen with a comprehensive understanding of end-to-end supply chain processes
- Excellent interpersonal and communication skills, capable of influencing without authority, at all levels of the organization, and handling partner relationships effectively with various cross-functional partners.
- Experience, training, or certification in Lean/Six Sigma
- Knowledge of product artwork management and ERP systems
- Requires proficiency in English (written and verbal) to communicate effectively and expertly
- Ability to work internationally across various time zones
- May require up to 20% domestic and/or international travel, depending on business requirements
- Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option of two remote workdays each week
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