While a member of the Akorn Technical Services organization, the Process Engineer will be located on the manufacturing site located in Decatur, IL. The Process Engineer will be responsible to provide the plant operations unit technical process expertise for a variety of pharmaceutical configurations produced on-site. The scope of work will include: standardizing and improving existing pharmaceutical manufacturing processes, inbounding new processes from R&D and/or process technology upgrades and product transfers.
1. The Process Engineer will lead high performing cross functional teams from implementation to final deliverable.
2. The Process Engineer will play an instrumental role in inbounding and scaling up R&D processes to full scale manufacturing including support for process validation.
3. The Engineer will also be responsible for troubleshooting existing processes and issues as needed.
4. He/she will be a key team leader on new product launches and product transfers.
5. The Process Engineer is responsible for leading the successful implementation of multiple projects as assigned within the plant and the Technical Services organization.
6. All projects will ensure best in class pharmaceutical manufacturing processes following QbD meeting quality and regulatory compliance requirements.
7. The Engineer will work across the enterprise and with cross-functional departments to ensure that the needs of manufacturing are being met. This includes ensuring successful, robust, compliant, and efficient manufacturing processes during scale-up, product launches, transfers, and troubleshooting.
1. Responsible for leading, coordinating, and managing projects in support of process inbounding/scale-up, product launches, transfers, and troubleshooting.
2. Responsible for managing changes in existing processes or process equipment including evaluation, justification, qualification and approval. Changes also include updating process related documentation including batch records, SOP's, submissions and reports as needed.
3. Standardize/modify existing manufacturing processes in an effort to increase robustness, reliability, and compliance.
4. Develop and implement product manufacturing process improvements for existing processes.
5. Troubleshoot and resolve manufacturing process issues while driving towards root cause definition and effective corrective actions.
6. Provide process engineering recommendations to R&D during the development phases to ensure the development of new products that can be manufactured robustly within the existing manufacturing technology or identify any new process technologies/equipment associated with product development activities.
7. Develop process documentation and training materials to support new or modified processes and new product launches.
8. Work with Plant and Global Engineering on process/equipment related needs.
9. Serve as Subject Matter Expert and Trainer for material directly related to process engineering knowledge.
10. Provide support and technical documentation for regulatory submissions as needed, product approval documentation, and other submission or approval related activities to ensure timelines are met.
11. Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.
12. Review/approve and/or prepare technical reports/summaries for all work performed.
13. Present process related data and communicate issues related to projects to upper management for review and discussion. Present strategies to Operations and Quality as needed.
1. Ensure that all drug products comply with cGMP, FDA and/or other appropriate regulatory guidelines
2. Participate in Technical Service and Operation's management and local plant staff meetings.
Process Improvements (Business)