Prepare line/equipment to fill aseptic products, in accordance with applicable standards (e.g., cGxP, SOPs).
Safety/Housekeeping: Keep work areas clean and free of hazards or dangerous conditions. Perform duties in accordance with HSE, dept. and company standards. Identify and report safety hazards or unsafe behavior.
Planning: Plan work activities in accordance with production schedule, and shifting priorities. Verify production schedule to determine and adjust activities according to production priorities. Ensure that materials needed for production runs are available. Coordinate work activities with coworkers, making good use of downtime.
Technical: Clean and prepare equipment for aseptic filling operations, in accordance with standards and procedures (cGxP, SOPs, etc.). Strictly adhere to Current Good Manufacturing Practices (cGMP), Current Good Documentation Practices (cGDP), and Standard Operating Procedures (SOPs). Resolve and/or report all discrepancies immediately. Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) on fill line equipment in accordance with SOPs and quality standards. Prepare fill line equipment for sterilization. Perform CIP, SIP, and Flush operations for all fill lines. Prepare and change out filters for aseptic and non-aseptic activities (e.g., Preventive Maintenance and sterile filtration). Complete required documentation (MBRs, SOPs, log books, etc.) in accordance with cGMP and cGDP. Troubleshoot and fix minor aseptic problems with line/equipment, alerting maintenance or supervisors as needed.
Team: Collaborate with co-workers to meet business objectives and enhance team capability. Share knowledge and experience with co-workers to develop team’s overall capability.
Interfaces: Coordinate with other shifts and departments to ensure smooth execution of work. Communicate and work with Quality Assurance on product quality issues and compliance activities. Communicate and work with Maintenance to resolve problems with equipment. Exchange accurate and complete information regarding production with supervisor, other shifts, and other departments. Communicate and work with Materials Control to ensure efficient flow of materials and products to/from warehouse. Communicate and work with Quality Control to ensure proper technique as well as good aseptic technique.
Sanitization Tech - 2nd shift