Process Engineer

Position Overview:

The Process Engineer will provide technical support to manufacturing and logistics operations. This includes troubleshooting, modifications, and improvements related to process systems, including clean-in-place, steam-in-place, washing, and sterilizing equipment. The engineer will be comfortable working in various production areas, such as CNC space, ISO classified rooms, and grey spaces.

Responsibilities:

• Technical Support: Troubleshoot and resolve technical issues related to process equipment, including upstream and downstream sysctems.
• Process Equipment Familiarity: Understand the operation and maintenance of upstream (incubators, bioreactors, centrifuges, pasteurizers) and downstream (chromatography columns, viral inactivation, ultrafiltration, diafiltration, freeze/thaw) equipment.
• Data Analysis: Use process data (e.g., temperatures, pressures, valve sequencing) to solve equipment-related issues.
• Regulatory Compliance: Support regulatory audits by gathering required documentation.
• System Design & Implementation: Select, design, and implement new or replacement systems for existing or new processes, automated systems, and equipment.
• Technical Issue Resolution: Identify root causes of technical issues and define corrective/preventive actions.
• Documentation & Training: Create and update operation and maintenance documentation, as well as training materials.
• Spare Parts & Preventive Maintenance: Identify and update spare parts and preventive maintenance procedures for new/modified equipment and systems.
• Commissioning & Validation: Support FAT, SAT, commissioning, and validation activities for equipment and automated systems.
• Safety & Quality Awareness: Contribute to safety and quality awareness within the department.
• Project Execution: Efficiently manage assigned projects and initiatives, ensuring they are completed on time and within budget.
• Support for Senior Engineers: Assist Senior and Principal Engineers with more complex projects as required.
• Cross-Functional Collaboration: Work with internal and external resources for assigned projects and contribute to Lean initiatives.

Reqirements:

• Biopharmaceutical Knowledge: Fundamental understanding of biopharmaceutical processes and equipment.
• Process & System Design: Develop understanding of process systems, equipment, and automated system design through coaching and support.
• GMP Understanding: Familiarity with GMP requirements and engineering fundamentals.
• Project Management: Understand project management methodologies and tools to advance projects.
• Problem Solving: Utilize tools such as the 5 Whys and Practical Problem Solving to address technical issues.