Principal Engineer, Technical Services (MS&T) Fill Finish
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
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 team of engineers 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.
• Provides leadership, support and guidance to Fill Finish Suite Team Leads
• 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
• Provides informal feedback on an ongoing basis and formal feedback in the annual performance
evaluation process to identify and develop talent.
• Participates in the implementation of divisional and company initiatives and strategies
• Ensures and promotes the development of the team/succession planning through coaching, training, and
• Primary point of contact for technical and operational equipment/process issues for 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. Provide leadership within assigned area or suite.
• 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 10 years related industry experience required, including 7+ years' experience in pharmaceutical/biotech operations in a technical role.
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred.