Manufacturing Engineer, Manufacturing (Fill Finish) Night Shift

The incumbent will be a member of theTeam at the Holly Springs Influenza Vaccine manufacturing facility supportingFill/ 24/7 Manufacturing Engineering function provides technical support and troubleshooting expertise to manufacturing organizations to achieve supply targetsmaximize 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 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. Troubleshootinvestigateand 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 materialswork instructions etc.). This function involves revising creating and withdrawing 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 complaintsdeviations or adverse process trends withinthe Bulk or Fill/Finish Manufacturing.
• Support process improvement projects toensure safe and efficient operations.

Requirements:

• Bachelors 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

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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