Pharmaceutical Packaging Engineer (5232)
Pharmaceutical Packaging Engineer – 5232 URA
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Project engineer who combines technical expertise with project leadership. Together he/she will strive to bring the best possible product to a successful launch!
You will work in the Manufacturing Science And Technology (MSAT) Large Molecule (LM) Platform, Primary Container Device (PCD) Launch & Grow team as a Packaging & Device Technical Launch Integrator (TLI). This team handles the technical transfer of newly developed products from R&D to Commercial Supply Chain.
This is a contract based opportunity with great chances of extension to be based in Schaffhausen, Switzerland.
- 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 Supply Chain technical voice at the right partner table.
- 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
- Device & Packaging 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 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.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- You hold a bachelor or master degree in engineering or science.
- 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.
- Demonstrate experience with applicable regulations; Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management; Qualification, Verification and Validation is a plus!
- Proficiency in English and German language is mandatory.Pharma