Production Operator (m/f/d), 100% (5/3 Shift)

• 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 review of batch documentation (part of production)
• Proper and timely cleaning, preparation and disinfection of production equipment and rooms
• Responsibility for housekeeping in 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 conducting process-related controls
• If applicable, delegated environmental monitoring for cleanrooms and delegated sampling of purified water and pure steam
• Immediate action in case of malfunctions, reporting anomalies to managers, experts and quality assurance operational staff
• Execution of all assigned tasks according to GMP, occupational safety and environmental guidelines
• Ensuring/monitoring proper functionality of equipment to detect early signs of anomalies. Taking appropriate measures in case of malfunctions.
• Excellent documentation of measures according to GMP regulations
• Management of consumable supplies required for proper operation (e.g. filters, resins, connectors, bags, reagents, gas, WCB, etc.)
• Segregation and disposal of waste generated during production activities
• Daily inspection of production equipment, auxiliary devices and rooms
• Clear and accurate documentation of necessary notes in batch documentation
• Participation in the creation of the production plan (reporting delays, incorrect duration of activities, etc.) and adherence to it
• Commitment and participation in operational excellence and continuous improvement
• Proper handling of biological and chemical substances in production
• Willingness for continuous improvement and analysis of weaknesses
• Participation in all function-relevant training and maintaining required training status
• Development and maintenance of an HSE-compliant environment: reporting near-accidents
• If required and applicable, occasional work on weekends/public holidays and scheduled on-call duty (shift system).

• Completed training
• Knowledge of technology and/or processes/products
• Team player with good team spirit
• Adaptability, ability to work under pressure
• High sense of duty and diligence (documentation, order and cleanliness at the workplace)
• Constructive working style, flexibility, solution-oriented, responsibility for own work, deep understanding of quality
• Self-motivation and ability to learn
• Fine motor skills (handling of analytical devices, microscopy, aliquoting)
• Good GMP understanding
• Good knowledge of MS Office and process control systems
• Basic technical understanding/automation

Questions?