Process Engineer Job in Charleston, South Carolina US
AAIPharma Services is a leading provider of drug development and manufacturing services to pharmaceutical, biotech and medical device companies around the world. With over thirty years of drug development expertise, we offer exciting and challenging career opportunities in a dynamic and growth oriented business. Our sterile manufacturing facility is located in Charleston, SC, a vibrant city well-known for its coastal beauty, climate, cultural arts, thriving business environment, and recent recipient of 1st place honors as the "Most Livable City in America" (US Conference of Mayors).
The Process Engineer will be responsible for providing technical support for the manufacturing of parenteral products for commercial distribution and clinical trials. Provides technical assistance that includes troubleshooting current validated processes, process deviations and investigation, transfer of new process and technologies into the Company and writing appropriate documentation to support all validation and process transfer activities. These functions will be executed by following standard operating procedures, batch records in accordance with FDA current Good Manufacturing Practices.
Key Job Responsibilities:
• Provide technical assistance for process transfer and validation efforts for assigned manufacturing and packaging projects.
• Composes process validation, cleaning validation, or process optimization protocols.
• Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Clearly and accurately document activities.
• Perform basic to moderate math calculations.
• Write validation and technical improvement reports with no approval authority.
• Provide input to Master Batch Records (equipment, critical process parameters, in-process tests, etc.).
• Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
• Assist technicians in performing physical testing during the aseptic manufacturing operation (e.g. sterilization, depyrogenation, lyophilization, sanitization).
• Participate in investigations and complete CAPA assignments.
Qualifications: