Manufacturing Engineer, Manufacturing - (Fill Finish) Night Shift
CSL
Summary
The incumbent will be a member of the Team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Fill/Finish Operations. The 24/7 Manufacturing Engineering function provides technical support and troubleshooting expertise to manufacturing organizations to achieve supply targets, maximize capacity and maintain equipment uptime.
Job description
This position is for a Night Shift Engineer working a 2-2-3 schedule. There are two Engineers on each night shift, plus overlap from the Manufacturing Engineering Manager during the 2-2 evenings of the schedule.
Responsibilities
- Providing technical support related to the process, equipment, and business systems across all departments within Fill/Finish Manufacturing. This function acts as front-line support of production and process-specific issues.
- Provide support to manufacturing as the first line of contact for technical and operational equipment/process issues. Troubleshoot, investigate and resolve a range of equipment problems in the manufacturing facility, leading the issue resolution effort and coordinating with appropriate teams as needed.
- Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.). This function involves revising, creating, and withdrawing documentation. This function should also assist with reviews and approvals of documentation.
- Ownership of quality records including incidents, DCEs, CAPAs, Level 1 and 2 change controls.
- Support evaluation actions for related change controls.
- Assist with investigations related to product and process including complaints, deviations, or adverse process trends within the Bulk or Fill/Finish Manufacturing.
- Support process improvement projects to ensure safe and efficient operations.
Requirements
- Bachelor’s degree in an engineering or science discipline or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred.
- Minimum 1 year of related industry experience required in the pharmaceutical/biotech industry.
Requirements
- Bachelor’s degree in an engineering or science discipline or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred
- Minimum 1 year of related industry experience required in the pharmaceutical/biotech industry
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.