at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The Manufacturing Specialist will work with the operation leadership and product development teams to propose and implement manufacturing processes for new products. They will also assist in the development of changes for existing products to reduce the opportunity for defects in drug manufacturing. Process improvements for LEAN manufacturing and Operational Excellence are also in scope for this role to provide additional value to the business and increase production while maintaining or reducing overhead cost. Currently this includes the transition of products from raw material compounding to sterile packaging from registered FDA drug manufacturers. The specialists’ role is also implementing electronic batch records for the operations team as they transition away from paper based systems.
Key Responsibilities
- Assist in the execution of new product development protocols as necessary including engineering runs, media fill, and stability studies
- Create new batch records and support documentation
- Draft and revise Standard Operating Procedures (SOPs)
- Author change controls for process updates
- Updating existing batch records for process improvements
- Train with the Deviation Management System (DMS) to write investigations
- Assist with commercial compounding and filling operations as necessary
