Device & Packaging Technical Project Manager.

Are you a senior Packaging engineering manager with great leadership quality, are you looking for new challenges, if you are interested to work for one of the biggest Medical device companies in the world then have a look at the job description below.

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.

•  Partnering end to end with drug product TLI(s) and other partners, you ensure a single JSC technical voice at the right partner table.
• You provide regular updates to partners and sponsors 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

Device & Packaging Technical Transfer:

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

Qualifications

Education:
 You hold a bachelor's 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 complex problems energizes you.
•  Through strong communication and your authentic personal leadership style, you are able to drive, contribute, and influence in different virtual teams successfully.
•  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:
Demonstrating 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 MANDATORY.
 Home office possible 2 days a week if the project allows and upon approval from the line manager
 Possibility of international travel up to 20%.

We are looking forward to your applications . Good luck