- Single-Use Equipment Expertise:
- Utilize expertise in TFF, Chrome, SU mixers, and LNP equipment to design, optimize, and troubleshoot processes
- Collaborate with vendors and internal teams to design SU components and create flow paths for new and existing processes
- Create and modify custom parts, flow paths, and assemblies to meet process requirements and improve efficiency
- Recipe and Design Testing:
- Develop and test recipes for SU equipment, ensuring optimal performance and product quality
- Conduct experiments and analyze data to optimize recipe parameters and process conditions
- Troubleshooting and Problem-Solving:
- Independently troubleshoot process equipment issues and implement corrective actions to minimize downtime and maintain production continuity
- Utilize analytical skills and technical expertise to diagnose root causes of process deviations and equipment failures
- Communication and Stakeholder Management:
- Communicate effectively with stakeholders, including vendors, cross-functional teams, and management, to coordinate SU component design, modification, and implementation
- Provide timely updates on process changes, troubleshooting efforts, and project status to stakeholders
- Change Control, Deviation, and CAPA:
- Manage change control processes for process modifications and equipment changes, ensuring compliance with regulatory requirements
- Investigate deviations and non-conformances, develop corrective and preventive actions (CAPAs), and implement solutions to prevent recurrence
- Fill/Finish Experience (Nice to Have):
- Utilize experience in fill/finish operations to support process optimization and troubleshooting efforts as needed
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related field (Master's degree preferred)
- 5+ years of experience in process engineering, with a focus on single-use equipment, preferably in the pharmaceutical or biotechnology industry
- Proficiency in designing and troubleshooting SU equipment, including TFF, Chrome, SU mixers, and LNP equipment
- Strong understanding of change control, deviation, and CAPA processes, with experience implementing corrective and preventive actions
- Excellent communication skills, with the ability to collaborate effectively with internal teams, vendors, and stakeholders
- Experience in fill/finish operations is a plus
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