Manufacturing Engineer I/II/III, Fill Finish 24/7 (Night Shift)

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‑linesupport 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.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit