Manufacturing Specialist - Specialty Injectables (3rd Shift)

Job description

Core Hours Monday - Friday, 10:00 pm - 6:30 am Purpose and Scope: The Manufacturing Specialist – Specialty Injectables serves in an advanced technical capacity, taking responsibility for the operation of complex equipment, optimizing processes, and mentoring junior staff. This role may primarily focus on either Injectables (Sterile Filling/Bulking), Bulking (Polymer), or encompass both areas. Key Responsibilities: - Act as the technical expert for setting up and operating complex manufacturing processes, handling all aspects of equipment setup, operation, disassembly, and cleaning independently. - Lead advanced troubleshooting efforts and resolve equipment and process issues as they arise. - Read and interpret reports, apply basic troubleshooting skills, and collaborate with Maintenance to address issues, such as filter testing, pressure hold tests, milling, SIP/VHP, PMS, and autoclave operations. - Take ownership of batch record documentation and corrections, including supporting deviation investigations. - Lead initiatives focused on process optimization and continuous improvement. - Mentor and train junior operators in advanced equipment operation and troubleshooting. - Perform...