Senior Technical Manager for Aseptics - Kundl, Österreich - Novartis

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

In this role you will be play a crucial part in the implementation for new aseptic powder and liquid filling lines (vials and syringes) and combination product equipment from design to successful commercial production of Antibiotics at FDF Kundl.

• Define user requirements for new equipment in alignment with Annex 1, establish proper aseptic handling processes and manage the corresponding qualification and validation activities in accordance with project budget and timelines together with a cross functional team.
• Act as Subject Matter Expert for new and established aseptic Fill & Finish processes including visual inspection and support of internal and external audits.
• Have an in-depth knowledge of aseptic manufacturing operations and process equipment to support Manufacturing, Quality, Automation and Validation
• Define and drive Opex initiatives to improve efficiency and output within the boundaries of aseptic manufacturing.
• Ensuring all the systems are in compliance with all Regulatory requirements