Engineer II/III (MS&T) Fill Finish

Job Purpose:

The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility and will be responsible for managing and leading a cross functional team to support the fill finish operations.   The MS&T organization at Holly Springs provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements. Provides front line support of production and process-specific issues.

 (Leadership)

• Provides leadership, support and guidance to the Inspection and Packaging fill finish lines  

• Create an inspiring team environment with an open communication culture

• Oversee day-to-day operations, set clear team goals, effectively delegate tasks and establish deadlines

• Establish and monitor process and operational KPI’s and report metrics

• Ensures compliance with established company and regulatory guidelines and procedures to provide high   

  quality service and outstanding performance

• Participates in the implementation of divisional and company initiatives and strategies

(Team Responsibilities)
• Primary point of contact for technical and operational equipment/process issues for the Inspection and Packaging areas within the fill finish organization.
• 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.
• Provide ownership of manufacturing documentation (procedures, batch records, training materials, specifications, etc.).
• This function involves creating, revising, and withdrawing documentation, including ownership of related CAPAs.
• Identify and implement continuous improvement projects to improve yield, reliability, process robustness, and safety.
• Lead weekly team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged.
• Lead after action review sessions and provide recommendations for improvement projects.
• Interface with maintenance, metrology, engineering, and quality to implement and update preventative maintenance plans.

Bachelor’s degree required.  Degree in an engineering or science discipline preferred.              

Minimum 3 years of related pharmaceutical/Biotech industry experience required, including a minimum 3+ years’ experience in aseptic manufacturing. 5+ years of experience preferred.

Strong organizational, time-management, and decision-making skills

In-depth knowledge of performance metrics

Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments.

Knowledge of automation and GMP documentation.

Ability to lead a Project to successful completion.

Strong Process improvement experience, certification in Lean/Six Sigma preferred

Proven organization, presentation, and time management skills

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.