Secondary Packaging Development Industrialization
il y a 1 semaine
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
To strengthen our **Device, Packaging and Wearable tech team**, we are looking for a high caliber, self-motivated, Secondary Packaging Development Industrialization Senior Expert based in **Braine l’Alleud, Belgium**
**At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.**
**You like to work in an** **environment where you will**:
- Participate in all activities linking secondary / tertiary packaging development within UCB global packaging operations internally and externally; the scope being global covering development, clinical supplies and commercial operations.
- The scope does not cover shipping qualifications or cold chain related development activities.
- Be the expert of the related supporting processes, which includes Technical Instruction (TI) process and supporting the technical database (in support of the UCB Commercial Global products).
- Lead projects from initial design concepts up to the industrialization completion and lifecyle management of secondary and tertiary packaging solution.
- Participate to SPA DIN strategy and participate to 10y plans and LRP for packaging operations, supported by the SPA Development lead and SPA industrialization Lead
- Support local (UCB Braine) & external packaging operations (CMO, from evaluation to implementation) by managing design validations studies, associated business case, ensure SOPs are followed and proper documentation of all packaging items are delivered on time.
- Project Management, including but not limited to change control management, where appropriate, communication in the team project and to stakeholders and management
- Responsible for development, implementation and continuous improvement of a global process on secondary/tertiary packaging development throughout the launch and the lifecycle of a drug product (including change management).
- Assure knowledge of legislation, international standards and guidelines on secondary/tertiary packaging requirements and assure appropriate communication and implementation within UCB's development and manufacturing activities.
- Project leader for multi-site projects
- Deliver technical expertise to support UCB sites, UCB affiliates as well as CMO's to ensure effective processes, optimize capacity utilization, quality, CoGs reduction and Green related objectives. Lead project groups, if appropriate. Support other business partners (purchasing, marketing,.) in case of specific requests.
- Lead multifunctional teams to ensure tech transfers, validation, investigation, and other business support activities to internal and external sites for secondary packaging activities for existing and new products.
- Business System Expert (BSE) for Technical Instructions processes and supportive system
- Business Process Expert (BPE) for the TI management including continuous improvement, point of contact for packaging sites (internal and external)
- Business Process Expert (BPE) for the Packaging Technical Files and Master BoM management including continuous improvement, point of contact for stakeholders
**Interested? For this position you’ll need the following** **education, experience** **and skills**:
- Experience in Project Management
- Significant operation management in GMP environment: 5-10 years
- International Exposure in pharmaceutical project management
- Proven experience in secondary packaging manufacturing environment
- Experience in Artwork management is a plus
- Can-do attitude with a positive mindset
- Excellent interpersonal, verbal and written communication skills
- Team player
- Autonomous, self-starting attitude, problem solving oriented, pragmatic
- Ability to balance efficiently multiple priorities
- Strong both analytical and conceptual thinking, able to understand and get clear picture on complex, technical and business issues
- Ability to be involved into multi-functional teams, influence others, hold accountability, results orient
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