Über die Tätigkeit

This individual is responsible for developing and delivering training for the aseptic fill area of the cleanroom as well as performing cleanroom technician responsibilities. Personnel will ensure all cleanroom training complies with regulatory requirements, good manufacturing practices and standard operating procedures.  Personnel will ensure that personnel are able to perform within the cleanroom aseptically and maintain good aseptic technique at all times. The trainer will also be responsible to ensure employees continue to follow correct procedures during manufacturing and review employees work to increase Right First Time (RFT) metrics.

Roles and Responsibilities:

• Assist with aseptic training specifically in the cleanroom for complex operations, including but not limited to, controlled products and automation.
• Personnel will coordinate with cleanroom lead to ensure personnel are maintaining proper aseptic technique in all areas of the cleanroom.   
• Coordinating with cleanroom supervisor to ensure personnel maintain proper training.
• Ensure all cleanroom personnel are adhering to all applicable Standard Operating Procedures
• Personnel will serve as secondary point of contact for communication within the cleanroom.
• Personnel will help in development of Standard Operating Procedures and process improvements.
• Personnel will ensure cleanroom technicians are operating aseptically at all times.
• Ensure all documentation in the cleanroom adheres to regulatory requirements, good manufacturing practices and standard operating procedures.
• Develops training modules in areas of expertise with an emphasis on aseptic related processes.
• Development of Proficiency tests applicable to required standard operating procedures.
• Cleaning the cleanroom facility and ensuring production cleaning tasks are completed.
• Aiding in aseptic audits.
• Preparing sterile products per batch record requirements.
• Performing environmental monitoring in the cleanroom
• Maintaining equipment as necessary
• Informing supervisors of problems that may arise
• Stocking the cleanroom with supplies and chemicals
• Ensuring that strict procedures are used in and around the cleanroom facility
• Cleaning of the general shipping and receiving area.
• Will assist with production operations as required.