Recovery of operations.
Complete filling operations
Complete unloading operations
Return equipment and facility to operational status
Cross-functional tasks including breakdown of equipment, sterilization of equipment and setting up for the next day’s activities.
Must be able to operate equipment
Essential Duties and Job Functions:
Assists in manufacturing and packaging of Gilead products. Works on routine assignments following Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Works in conjunction with other Manufacturing Technicians under the guidance of a Team Leader and the Manufacturing Manager. Sets up, operates, and troubleshoots aseptic filling equipment and lyophilizer autoloading equipment in classed cleanroom environments. Cleans (manually and CIP) and assembles equipment for production. Prepares equipment and components for sterilization. Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel. Performs CIP and SIP of tanks Cleans manufacturing areas, including walls, ceilings and floors. Performs annealing and sterile filtrations of products. Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line. Performs detailed JDE (computerized software) transactions in resolving inventory discrepancies. Performs other duties as assigned May be required to perform duties of Packaging Tech or Manufacturing Tech I and II positions during periods of increased activity. Complies with all safety-related procedures and practices personally and in work area. Has daily interaction with department members to ensure production proceeds as scheduled. Required to report variance or deviation from standard procedures to department management.
Knowledge, Experience and Skills:
Typically requires a HS diploma and minimum 5 years of relevant experience. Works on assignments that are routine in nature where ability to recognize deviation from accepted or usual practices is required. Receives general instructions on routine work, and detailed instructions on new assignments. Follows written Standard Operating Procedures (SOPs) and Master Batch Records and must be able to take variant action only with approval of department management.
Gilead - 24 months ago