Entity: CSL Seqirus

Job Category: Manufacturing Operations

Job Family: Manufacturing Operations Multi Discipline

Job Type: Full Time

Location: Holly Springs, North Carolina, United States

Employer Reference: R-283948

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.

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.