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Job Description

Janssen Pharmaceutical is recruiting for a Packaging & Device Technical Project Manager/Launch Integrator (f/x/m), located in Schaffhausen, Switzerland.

Devices and Packaging solutions are becoming an increasingly meaningful component in delivering innovative medicines to our patients. We are looking for an extra colleague who combines technical expertise with project leadership. Together we strive to bring the best possible product to a successful launch! You will work in the New Product Launch and Grow team within the MSAT Large Molecule Platform. This team handles the technical transfer of newly developed products from Janssen R&D to Janssen Commercial Supply Chain (JSC).

Key Responsibilities: Project Leadership and Technical Launch Management

You lead different global and local project teams and act as a core team member in the value chain team.

You provide regular updates to partners and sponsor through reports, presentations and ad-hoc communication.

All technical outputs for file submission and launch readiness are completed by you, 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

Product Technical Transfer

You work with the Primary Container & Device development team (PCD) to optimize the design of device and primary container for commercial assembly, packaging and distribution.

Together with internal partners and suppliers, you search for optimal off-the-shelf and custom designed device components and secondary packaging materials solutions. You integrate customer insights, standard platforms and requirements from various partners 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 outstanding examples and standard procedures.

Project engineers are your key partners to ensure that equipment is accurately 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.

Job Qualifications

Qualifications

Education

You hold a bachelor or master degree in engineering or science.

Required

Experience and Skills:

You love guiding projects from initiation to completion with a multifunctional team in a global context.

Working towards ambitious goals and solving sophisticated problems energizes you.

Through strong communication and your authentic personal leadership style, you are able to successfully drive, contribute and influence in different virtual teams.

You bring at least 5 years of solid experience in device and packaging operations, engineering, project management or R&D, preferably in the pharmaceutical, medical device or fast moving consumer goods industry.

Preferred

Demonstrate experience with applicable regulations; Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management; Qualification, Verification and Validation is a plus!

Other

Proficiency in English and German language is required.

What’s in it for you?

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment 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 Schaffhausen, Switzerland, you will be member of a global team across US and Europe. You will have the flexibility to work from home up to 40%. You will find opportunities for personal and professional growth by working with a diverse group of people across our organization. You may be requested to travel internationally up to 10%.

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Join us!

Primary Location

Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization

Cilag GmbH International (8525)

Job Function

Engineering (Generalist)

MSAT Principal Engineer

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