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Senior Manufacturing Process Consultant

vor 3 Monaten

Langkampfen, Österreich Novartis Vollzeit

Location: Austria, Schaftenau


As a Senior Process Expert, you will deliver essential technical and scientific expertise for all process-related challenges to guarantee timely execution of operations (business continuity); ensuring adherence to cGMPs, SOPs, and relevant guidelines and functional standards (e.g., HSE, NOSSCE) while continuously enhancing quality and productivity efficiency.

Your role will also encompass responsibilities as the accountable individual ('Herstellungsleiter') for the production of finished products ('Halbfertigprodukt' and 'Fertigprodukt') in accordance with §8 of Arzneimittelbetriebsordnung (AMBO) 2009.

This position collaborates closely with the Manufacturing Team and reports directly to the Process Support Unit Lead.

Key Responsibilities:

Your responsibilities include, but are not limited to:

  • Deliver expert support in the coordination and production of biopharmaceuticals.
  • Facilitate fundamental GMP processes.
  • Develop production support documentation and concepts, as well as prepare for internal and regulatory audits.
  • Provide real-time shop floor assistance as a technical expert, ensuring timely completion of all production tasks in compliance with documentation and GMP, SSE, and 5S standards.
  • Identify, initiate, and coordinate improvement initiatives within the production environment.
  • Conduct training sessions for production staff on industrial hygiene, GMP, and safety protocols.
  • Oversee the execution and interpretation of study results, along with the provision and assessment of process-relevant data.
  • Manage deviations, implement and coordinate defined actions, and execute approved change requests.