Engineer II/III, Technical Services Fill Finish Operations
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 leading a cross-functional team of SME and Area Leaders specific to formulation and adjuvant production in the commercial fill finish manufacturing operation. 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 to drive strategic improvements. Additionally, this role provides front line support of production and process-specific issues.
- Provides leadership, support and guidance to the Formulation and Adjuvant Commercial Manufacturing Suite Team
- Lead weekly team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged.
- Primary point of contact for technical and operational equipment/process within the formulation and adjuvant manufacturing space.
- Monitor and/or establish process and operational KPI’s and report on suite metrics
- Troubleshoot and investigate equipment and process issues within 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, etc.).
- Create, Revise, and Withdrawing documentation, including ownership of related CAPAs.
- Identify and implement continuous improvement projects to improve yield, reliability, process robustness, and safety.
- Lead after action review sessions and provide recommendations for improvement projects.
- Develop and encourage an inspiring team environment with an open communication culture
- Effectively delegate tasks and establish deadlines
- 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 2+ years’ experience in aseptic filling. 5+ years of experience preferred.
- Proven work experience as a team leader or supervisor with strong organizational, time-management, and decision-making skills
- In-depth knowledge of performance metrics and statistical process control
- 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