Engineer I/II/III (MS&T) Bulk Manufacturing
The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility and will be a contributing member of a cross-functional team of SME and Area Leaders specific Bulk production in a commercial 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 support and guidance to the Bulk Commercial Manufacturing Operation
• Review/track performance metrics and project statuses.
• Primary point of contact for technical and operational equipment/process within the purification manufacturing space.
• Monitor and/or establish process and operational KPI’s and report on suite metrics
- Identify and implement continuous improvement projects to improve yield, reliability, process
robustness, and safety.
• 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,
• Create, Revise, and Withdraw 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 cultureMinimum requirements:
- 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
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