Process Engineer
Process Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 cleaninplace steaminplace 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 equipmentrelated 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 : 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.
- CrossFunctional 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.
Employment Type
Full Time
