Techniker/in - Biotechnik

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Process Expert (m/f/d) - Schaftenau, Tirol Job ID REQ-10074844 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. 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 language skills (spoken and written). Desirable Qualifications: * Self-driven and independent working style; ability to take ownership of topics from initiation to completion. * Strong communication and collaboration skills, comfortable working with diverse teams. * Hands-on mindset - willing to enter production areas, interact with operators, and work directly with equipment; technical affinity required. * Experience working in a GxP environment/GMP knowledge is an advantage.

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