Manufacturing Engineer, Manufacturing - (Fill Finish) Night Shift

CSL Vifor; Holly Springs (NC); On-site; USD 90,000 - 110,000; Full time

Job summary

CSL Vifor in Holly Springs is seeking a Night Shift Engineer for the Fill/Finish Manufacturing team. The role supports process, equipment, and business systems across departments, acting as the frontline for technical issues and coordinating resolutions during a 2-2-3 night shift.

The position requires a bachelor’s degree in engineering or science and at least 1 year of pharma/biotech experience. Responsibilities include documenting procedures, batch records, CAPAs, and supporting change

Qualifications

• Bachelor’s degree in engineering or science is required or equivalent experience.
• Minimum 1 year of related industry experience in pharmaceutical/biotech.

Responsibilities

• Providing technical support related to the process, equipment, and business systems across all departments within Fill/Finish Manufacturing.
• 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.
• Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.).
• 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.

Skills

Technical troubleshooting

Documentation

Education

Bachelor’s degree in engineering or science

Job description

The incumbent will be a member of theTeam at the Holly Springs Influenza Vaccine manufacturing facility, supportingFill/FinishOperations.The 24/7 Manufacturing Engineering function provides technical support and troubleshooting expertise to manufacturing organizations to achieve supply targets,maximize capacityand 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 technicalsupportrelated to the process, equipment, and business systemsacross all departments withinFill/Finish Manufacturing.This function acts asfront-linesupport of production and process-specific issues.
• Provide support to manufacturing as thefirst lineof contact for technical and operational equipment/process issues. Troubleshoot,investigateand resolvea range of equipment problems in the manufacturing facility, leading the issue resolution effort and coordinating with appropriate teams as needed.
• Author and improvemanufacturing 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 withinthe Bulk or Fill/Finish Manufacturing.
• Support process improvement projects toensure safe and efficient operations.

Requirements:

• Bachelor’s degree in an engineering or science discipline or equivalent experience in pharmaceutical, manufacturing, or equivalent industrypreferred.

Minimum 1 year of related industry experience required in thepharmaceutical/biotechindustry