Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Principal Engineer, Device and Packaging Technical Launch Integrator (f/x/m)

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 profound device and packaging expertise with technical 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 Biotherapeutics Platform. This team leads the technical transfer of newly developed products from R&D to the J&J Commercial Supply Chain.

Key Responsibilities:

Early Development and Technical Transfer

You will work proactively with internal and external teams in assessing new concepts, support "Test and Learn” phase and evaluate prototypes against pre-determined performance parameters

You will identify the required capabilities to prepare for new product pipeline. Supporting the introduction of new capabilities and modalities such as material sciences, automation, electro mechanical and digital and connected health capabilities.

In Early Development phase, you will support benchmarking process for Device and Packaging, identify trends and develop appropriate actions and plans in partnership with specialist external and internal teams.

• Assessing the feasibility of new technologies and also identifying suppliers for new technologies in collaboration with R&D

• Participating in forums to understand best practice and leverage common technologies

• Function as the Early Development Contact – partnering proactively with R&D Teams to develop an understanding of potential device and packaging requirements at an early stage and translating those requirements for the Supply Chain

• Forge effective partnerships with key functions to develop breakthrough solutions to successfully support product launches with an end to end mindset.

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.

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, the global 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.

Experience and Skills:

Required:

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 10 years of solid experience in device and packaging operations, engineering, project management or R&D, preferably in the pharmaceutical or medical device industry

Preferred:

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

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 at one of our JJIM sites, 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!