Manufacturing Engineer I - Day Shift (6am-6pm)

Job Purpose:

The incumbent will be a member of the 24x7 Manufacturing Support Team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk or Fill/Finish Operations.  The 24x7 Manufacturing Support function provides technical support and troubleshooting expertise to manufacturing organizations to achieve supply targets, maximize capacity and maintain equipment uptime. This position has responsibilities that include providing technical support related to the process, equipment, and business systems across all departments within Bulk or Fill/Finish Manufacturing. This function acts as front-line support of production and process-specific issues.

• Shift - 12 hour shift
• Hours: 6am to 6pm
• Schedule: 2,2,3

• Provide support to manufacturing as the first line of contact for technical and operational equipment/process issues. Troubleshoot and investigate equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
• Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related CAPAs.
• Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity. Identify and implement continuous improvement projects to ensure safe and efficient operations.
• Learn, understand and work within a matrix organization to resolve issues and drive performance
• Own or assist with investigations related to product and process including complaints, deviation, or adverse process trends within Bulk or Fill/Finish Manufacturing.
• Coordinate with vendors, MS&T and supplier management for third party complaints.
• Interface with maintenance, metrology, engineering, MS&T and quality during troubleshooting of manufacturing issues.

• Ensure protocols are executed as intended
• Support execution of process validations and annual monitoring of batches
• Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution

• Bachelor’s degree or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred.  
• Degree in an engineering or science discipline preferred.
• Minimum 1 year of related industry experience required in the pharmaceutical/biotech industry
• Experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments is preferred
• 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.
• Proven organization, presentation, and time management skills.
• Willingness to learn all areas within Bulk or Fill/Finish Manufacturing and the different systems required to support continuous improvement.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.