Safety/Housekeeping: Keep work areas clean and free of hazards or dangerous conditions.
Perform duties in accordance with HSE and company standards/guidelines. Identify and report safety hazards or unsafe behavior.
Planning: Plan work activities in accordance with production schedule, and shifting priorities. Ensure that materials needed for production runs are available.
Technical: Operate equipment to package products, in accordance with standards and procedures (cGMP, SOPs, etc.). Strictly adhere to Current Good Manufacturing Practices (cGMP), Current Good Documentation Practices (cGDP), and Standard Operating Procedures (SOPs) and report all discrepancies and/or deviations immediately to Production Management.
Monitor and control all operations of steam, dry heat and water cascade sterilization processes to ensure that all parameters have been met. Maintain, test, prepare, and sterilize vent filters for sterilizers. Perform trend analysis of data relevant to the safe and efficient operation of all sterilizers.
Interface with computer automation systems to effectively operate, document and trend Sterilization systems. Complete required documentation accordance with cGMP and cGDP. Troubleshoot and fix minor problems with sterilizer equipment and alerting maintenance or supervisors as needed.
Complete all required training and maintain all certification requirements. Become sterile garbing certified to unload sterilizers in a sterile environment. Review and check sterilizer loads, load configuration sheets, cycle charts and cycle reports to assure conformance to all internal and external procedures and regulations.
Monitor in process cycles and alert Sterilizer Maintenance and Production Management if sterilizer issues are detected. Assure all components and/or equipment are sterilized prior to production needs. Issue work orders for repair of equipment or potential safety issues involving sterilizer operations. Maintains proper records to comply with established procedures and cGMP requirements
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.