Technical Launch Integrator, Device and Packaging
Vor 5 Tagen
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices.
Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major globalmarkets.The Schaffhausen facility is a Johnson& Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
Device and Packaging solutions are becoming a more important component in delivering innovative medicines to our patients. We are looking for a team member who combines technical expertise with project leadership. Together we aim to bring the best possible product and process to a successful new product launch. You will work in the New Product Introduction (NPI) team at the Device and Packaging Center of Excellence (CoE). This team manages the technical transfer of newly developed products from Janssen R&D to Janssen Commercial Supply Chain (JSC).
**Technical Launch Integrator, Device and Packaging CoE, Location: Schaffhausen, Switzerland**
Job responsibilities
Your responsibilities as a device and packaging TLI will include, among others:
Project Leadership and Technical Launch Management
- You lead complex global and local project teams, you are a core team member in the value chain team and the supply chain development team.
- You partner with the drug product, drug substance and E2E TLI to ensure a single JSC technical voice at the right stakeholder table.
- You provide regular updates to project stakeholders and sponsors through regular reports, presentations, and ad-hoc communication.
- You ensure that all technical deliverables for health authority submissions and launch readiness are completed on-time and with the right quality.
- You provide up to 1 year of post-launch support to ensure manufacturing stabilization and fluent transfer of ownership to base business.
Device & Packaging Technical Transfer
- You work with the Primary Container & Device development team (PCD) to optimize design of device and primary container for commercial assembly, packaging, and distribution.
- You work with internal partners and suppliers to search for best possible off-the-shelf and custom designed device components and secondary packaging materials solutions.
- You integrate customer insights, standard platforms, and requirements from various stakeholders in Research & Development (R&D), the global Janssen Supply Chain organization and the production site.
- You ensure accurate specifications and adequate controls are in place.
- You drive development, implementation, and validation of the device assembly and packaging processes at commercial scale and according to best practices and standard procedures.
- You partner with project engineers to ensure that assembly and packaging equipment is properly designed, tested, installed, and qualified.
- You deliver a robust tech transfer documentation set in-line with applicable combination product and packaging design transfer procedures. This includes a design transfer plan and report, control strategy, FMEA, equipment qualification and process validation, distribution testing, procedures, protocols, ad-hoc test protocols, data analysis and summary reports.
**Qualifications**
- You enjoy guiding projects from initiation to completion with a multi-functional team in a global context.
- You enjoy working towards challenging goals and solving complex problems.
- You are an excellent communicator and are able to effectively drive, contribute and influence in different virtual teams through appropriate means of communication.
- You hold a bachelor or master degree in engineering or science.
- PMP/FPX certification is preferred.
- You possess the ability to build, and lead global complex cross-functional teams is required
- You have at least 7 years of relevant experience in device and packaging operations, engineering, project management or R&D, preferably in the pharmaceutical, medical device or fast moving consumer goods industry.
It is a plus if you can demonstrate experience with applicable regulations; Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management; Qualification, Verification and Validation.
What’s in it for you?
J&J is the biggest health company in the world. Therefore, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of creating a nice workplace where everybody feels welcome and respected. At J&J we recognize the importance of a good work-life balance. We will also give you the space and opportunities to grow and learn during workshops and training sessions.
Based out of Janssen facility in Schaffhausen, Switzerland, you will be member of a global team located across t
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