| Process Engineer Columbia, MD (Onsite) at Columbia, Alabama, USA |
| Email: [email protected] |
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From: Yogesh Sharma, StellentIT [email protected] Reply to: [email protected] Process Engineer Columbia, MD (Onsite) Phone + Skype Job descripton: 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. Key Responsibilities: General Responsibilities: Technical Support: Troubleshoot and resolve technical issues related to process equipment, including upstream and downstream systems. 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. Engineering Core Responsibilities: 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 & Activity Management: 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. Knowledge & Skills: 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. Keywords: Maryland Process Engineer Columbia, MD (Onsite) [email protected] |
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| 05:09 AM 02-Apr-25 |