Key Responsibilities:
Process Design & Optimization
- Contribute to the design and development of biological production processes and systems.
- Analyze and optimize process parameters to improve yield, quality, and efficiency.
- Drive continuous improvement initiatives to enhance process capability and production output.
Commissioning & Qualification (CQ)
- Participate in commissioning and qualification of new process equipment and systems.
- Support FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) during equipment build-outs.
- Develop user and functional specifications for process equipment.
Equipment & System Management
- Design, install, and commission new production units, including upgrades and modifications.
- Lead or support troubleshooting of process and equipment issues.
- Propose and evaluate modifications to improve safety, efficiency, and reliability.
cGMP Compliance & Change Control
- Ensure process and equipment modifications comply with cGMP and quality standards.
- Document and validate all process changes in line with regulatory requirements.
Production Support
- Maintain safe, reliable manufacturing systems to meet supply and quality needs.
- Reduce costs, changeover time, and downtime while increasing productivity and throughput.
- Provide support to operations teams during production campaigns.
Cross-functional Collaboration
- Partner with engineering, manufacturing, quality, and EHS teams to align on goals and resolve issues.
- Provide technical input and support for process risk assessments and safety reviews.
Other Duties
- Perform other tasks assigned by the reporting manager.
- Travel as required for project or equipment-related activities.