Process Expert (m/f/d) - Schaftenau, Tirol

Job description

Job Description Summary As a Process Expert, you will play a key role in ensuring the reliable, compliant, and efficient execution of aseptic filling processes within a highly regulated pharmaceutical environment. Job Description: Main Responsibilities: - Ensure business continuity for aseptic syringe‑filling operations by providing expert process support. - Handle deviations end‑to‑end, ensuring timely investigation, documentation, and release of batches. - Develop, own, and continuously improve processes, including writing and optimizing process documentation. - Create and maintain life‑cycle documents to ensure compliance, accuracy, and inspection readiness. - Represent the company as a Subject Matter Expert (SME) during Health Authority (HA) inspections. - Collaborate with cross‑functional departments and manage stakeholders to align expectations and resolve issues efficiently. - Participate in validation and qualification activities, supporting equipment, process, and system readiness. Minimum Requirements: - Completed technical or scientific degree (e.g., Process Engineering, Biotechnology, Technical Chemistry) or a comparable qualification. - Strong English and German langua...