Pharmaceutical Batch Maker

#MedixNE

• Execute bulk product batch processing, including all related process and administrative tasks, as well as equipment preparation activities, as outlined in Compounder 1 responsibilities.
• Adhere to manufacturing procedures to ensure accurate and efficient processing of bulk products, with an emphasis on getting batches right the first time.
• Perform compounding functions as directed by operations management and where qualified.
• Operate processing equipment and conduct manual and automated cleaning, sanitizing, and sterilization of tanks and equipment as required.
• Conduct integrity testing of filters using automated filter integrity test equipment.
• Follow detailed diagrams and written instructions to assemble or disassemble equipment, and prepare equipment for washing or autoclaving.
• Demonstrate competency progression across all aspects of the role.
• Handle multiple tasks simultaneously and demonstrate aptitude for multitasking.
• Successfully complete sterile gowning qualification within the specified timeframe.
• Perform environmental monitoring and testing of clean rooms, ensuring compliance with grade C and D standards.
• Actively engage in troubleshooting processes as needed, utilizing knowledge and experience.
• Maneuver drums and equipment weighing over 50 lbs, and lift weights up to 50 lbs as required.
• Maintain accurate and thorough documentation for all duties performed.
• Understand and comply with current SOP and GMP requirements relevant to the position.
• Maintain professional, courteous, and effective communication with coworkers.
• Ensure job responsibilities are carried out in a safe and efficient manner, maintaining a clean work environment.
• Assist supervisors and process managers with additional duties as assigned.
• Properly use personal protective equipment at all times.
• Perform routine maintenance on process equipment.
• Conduct area cleaning using phenolic cleaners and sporicidal agents, with appropriate respiratory protection as needed.
• Review Manufacturing Batch Records throughout the process to ensure compliance with good documentation practices.
• Be available for unscheduled and scheduled overtime during weekdays and weekends as requested.