Production Operator (m/w/d), 100% (5/2 Schicht oder 5/3 Schicht)

Tasks: • Participation in manufacturing processes • Execution of all assigned tasks according to the production plan and valid GMP, work, operational, environmental, and safety instructions and guidelines • Timely and error-free verification of batch documentation (part of production) • Proper and timely cleaning, preparation, and disinfection of production facilities and rooms • Responsibility for managing the production area (cleaning, order, 5S, etc.) • Compliance with and enforcement of health, safety, and environmental rules and guidelines (HSE) • Application and enforcement of current GMP rules • Sampling, aliquoting, distribution, and implementation of process-related controls • If applicable, delegated environmental monitoring for clean rooms and delegated sampling of purified water and steam • In the event of a malfunction, taking immediate action, reporting anomalies to managers, experts, and operational quality assurance • Execution of all assigned tasks according to GMP, occupational safety, and environmental guidelines • Ensuring/monitoring proper functionality of facilities to detect early signs of anomalies, taking suitable measures in the event of a malfunction • Excellent documentation of measures according to GMP regulations • Management of consumable supplies required for proper operation (e.g., filters, resins, connections, bags, reagents, gas, WCB, etc.) • Separation and disposal of waste generated during production activities • Daily inspection of production facilities, auxiliary equipment, and rooms • Clear and accurate documentation of necessary notes in batch documentation • Participation in creating the production plan (reporting delays, incorrect activity duration, etc.) and adhering to it • Commitment to and participation in operational excellence and continuous improvement • Proper handling of biological and chemical substances in production • Willingness to continuously improve and analyze weaknesses • Participation in all function-relevant training and maintaining a required level of training • Development and maintenance of an HSE-compliant environment: reporting near-misses • If required and applicable, occasionally working on weekends/holidays and having scheduled on-call duty (shift system) Requirements: • Completed training • Knowledge of technology and/or processes/products • Team player with good team spirit • Adaptability, ability to work under pressure • High sense of responsibility and carefulness (documentation, order, and cleanliness in the workplace) • Constructive way of working, flexibility, solution-oriented, responsibility for one's own work, deep understanding of quality • Self-motivation and ability to learn • Fine motor skills (handling analytical equipment, microscopy, aliquoting) • Good understanding of GMP • Good knowledge of MS Office and process control systems • Basic technical understanding/automation