Manufacturing Engineer I/II (Day shift)

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-276119

Job Description

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

You will be a member of the 24x7 Manufacturing Support Team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk Manufacturing Operations. The 24x7 Manufacturing Support function provides front-line technical support and troubleshooting expertise to manufacturing organizations to achieve supply targets, maximize capacity and maintain equipment uptime. You will report to the Senior Manager, Production Support.

• Shift: Days
• Hours: 6AM - 6PM
• Follows 2-2-3 schedule

Responsibilities

• Provide support to manufacturing as the first line of contact for technical and operational equipment/process issues.
• Troubleshoot, investigate and resolve simple/minor equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. This function should assist in triaging issues and properly escalating with a proposed plan of action when additional support is required.
• Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.) with oversight from area owners and SMEs. This function involves revising and withdrawing documentation.
• Manage quality records including minor deviations and incidents, simple DCEs (i.e. single system disruptions), procedural and minor impact CAPAs. Assist with investigations related to product and process including complaints, deviations, or adverse process trends within the Bulk Manufacturing. This function may require oversight from 24/7 Support Team manager, area owners or SMEs.
• Support process improvement projects to ensure safe and efficient operations.
• Coordinate with vendors, MS&T, and supplier management for third party complaints.
• This function should possess a basic understanding of all areas and operations within Bulk manufacturing. Provide support for manufacturing on business systems including GLIMS, SAP and other systems.

Qualifications:

• Bachelor's degree or equivalent, or equivalent vocational or technical education. Level of role commensurate with related industry experience (pharmaceutical/biotech operations preferred).
• Experience within Manufacturing operations
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
• Strong understanding of engineering, equipment, and automation principles.
• Strong mechanical aptitude or knowledge of electronic / mechanical equipment is required.
• High attention to detail in order to solve a range of routine and non-routine problems.

This employee will be expected to work with support from other functions to perform tasks. Guidance will be given from team members or management to assist them in completing their job functions.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is 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.


To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at



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