Process Engineer II

1 month ago


Durham, United States CARsgen Therapeutics Full time

Position Summary:

The Process Engineer II at CARsgen Therapeutics' Durham facility is a technical role and it is a great opportunity to grow your career within Maintenance and Engineering areas supporting leading-edge CAR-T therapy manufacturing. The individual in this role must prioritize and coordinate the maintenance of process, facility, and analytical equipment at the GMP manufacturing facility. This individual must actively manage his/her schedule and external suppliers to reliably support facility/utility operations and production systems. Additionally, the selected individual must become proficient in the use of the computerized maintenance management system and manage the usage of the system for maintenance operations.

Responsibilities:

  1. Coordinate maintenance activities with internal stakeholders and vendors within a GMP process facility.
  2. Thoroughly review controlled documentation for clarity and traceability.
  3. Assist in the development and maintenance of standard operating procedures (SOP) and equipment forms/logbooks for the department
  4. Maintain CMMS (Blue Mountain Regulatory Asset Manager) assets, PM schedule, maintenance work orders and associated documentation.
  5. Maintain Vaisala Environmental Monitoring System.
  6. Maintain facility drawings (P&ID’s, Floorplans, etc.).
  7. Assist with investigations and action items to support Deviations, CAPA’s, and Change Controls.

Qualifications:

  1. Bachelor’s degree in engineering or life science related field and a minimum of three years of experience in a GMP manufacturing environment
  2. Coordination experience and knowledge of maintenance principles within a manufacturing and GMP process facility.
  3. Previous experience working in a cleanroom or GMP/regulated manufacturing environment.
  4. Strong communication and organizational skills.
  5. Flexibility to perform various tasks and ability to prioritize based on business needs.
  6. Analytical and technical skills to work through and troubleshoot equipment and instruments.
  7. Experience maintaining supportive facility & utility equipment in a GMP regulated facility.
  8. Experience with GMP process and analytical equipment such as incubators, refrigerators and freezers, biological safety cabinets, small bioreactors, centrifuges.
  9. Experience working with a CMMS (Blue Mountain, SAP, Maximo, etc) and managing maintenance work orders and associated documentation.
  10. Experience working with AutoCAD for drawing management is a plus (preferred).
  11. Previous experience handling Deviations, OOT, CAPAs, and Change Controls for equipment within a QMS framework.
  12. Ethics and Integrity.

  • Process Engineer II

    1 month ago


    Durham, United States CARsgen Therapeutics Full time

    Position Summary:The Process Engineer II at CARsgen Therapeutics' Durham facility is a technical role and it is a great opportunity to grow your career within Maintenance and Engineering areas supporting leading-edge CAR-T therapy manufacturing. The individual in this role must prioritize and coordinate the maintenance of process, facility, and analytical...


  • Durham, North Carolina, United States Novo Nordisk AS Full time

    Role Overview:As a Process Engineer II, you will play a crucial role in enhancing and innovating systems and machinery essential for our core operations. Your efforts will ensure compliance with customer expectations, business objectives, and regulatory standards.Key Responsibilities:- Focus on People: Collaborate with cross-functional teams to foster a...


  • Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time

    Job OverviewHumacyte, Inc. is pioneering a groundbreaking scientific technology platform, creating bioengineered products that are universally implantable and readily available, aimed at enhancing patient outcomes and revolutionizing medical practices. The organization specializes in the development and manufacturing of acellular tissues, addressing a...

  • Process Engineer

    2 months ago


    Durham, United States ROYAL METAL POWDERS, LLC Full time

    Job DescriptionJob DescriptionDescription:The Process Engineer will lead process support and improvement for metal powder manufacturing, providing guidance to shift crews, production, and maintenance. This position works with a cross functional team of engineers including process engineers, project engineers and metallurgists. The Engineer will be primarily...

  • Process Engineer

    3 days ago


    durham, United States Compunnel Inc. Full time

    🚀 Join Our Team as a Senior Process Engineer III in Hickory, NC! 🚀Are you a seasoned Process Engineer with a passion for high-speed cable manufacturing and process excellence? We're looking for a talented individual to lead and innovate in our dynamic team. If you thrive in a collaborative environment and excel at problem-solving with data-driven...

  • Process Engineer

    4 days ago


    durham, United States Compunnel Inc. Full time

    🚀 Join Our Team as a Senior Process Engineer III in Hickory, NC! 🚀Are you a seasoned Process Engineer with a passion for high-speed cable manufacturing and process excellence? We're looking for a talented individual to lead and innovate in our dynamic team. If you thrive in a collaborative environment and excel at problem-solving with data-driven...

  • Process Engineer

    5 days ago


    Durham, United States Compunnel Inc. Full time

    🚀 Join Our Team as a Senior Process Engineer III in Hickory, NC! 🚀Are you a seasoned Process Engineer with a passion for high-speed cable manufacturing and process excellence? We're looking for a talented individual to lead and innovate in our dynamic team. If you thrive in a collaborative environment and excel at problem-solving with data-driven...

  • Process Engineer

    1 month ago


    Durham, United States Cormetech Inc Full time

    Job DescriptionJob DescriptionDescription:Summary:The Process Engineer is responsible for making sure the oven and activation areas are meeting goals for throughput, yield, and equipment uptime. They also ensure high quality products are manufactured in a safe and efficient manner. The position will also maintain control of the manufacturing process. As a...


  • Durham, North Carolina, United States PowerSecure, Inc. Full time

    Job OverviewPosition Summary:The Electrical Controls Engineer II is responsible for the design and enhancement of electrical and control systems for our product lines. This role involves ensuring that all designs comply with relevant engineering documents and industry standards, such as UL and NEC, to guarantee the safety, quality, and performance of our...


  • Durham, North Carolina, United States PowerSecure International Full time

    Job Summary:The Electrical Design Engineer II provides electrical and controls design expertise on product improvements for electrical and controls infrastructure of our manufactured product lines, as well as coordinates site-wide drawings as applicable per site/project. This role ensures that our equipment/sites/projects are built and/or applied per...


  • Durham, United States Corning Incorporated Full time

    In this role, you will be responsible for supporting Cornings sterilization technology and terminal sterilization processes across the CLS division. We look for you to support of development, engineering, and manufacturing projects. You will need to Process Engineer, Engineer, Operations, Leadership, Support, Process


  • Durham, North Carolina, United States PowerSecure, Inc. Full time

    Job OverviewPosition Summary:The Electrical Controls Engineer II is responsible for the design and enhancement of electrical and control systems for our product lines. This role involves ensuring that our projects adhere to engineering specifications and relevant industry standards, including UL and NEC. The primary objective is to guarantee the safety,...


  • Durham, North Carolina, United States CARsgen Therapeutics Full time

    Join Our Innovative Team at CARsgen TherapeuticsWe are excited to announce an opening for a Process Engineering Specialist at CARsgen Therapeutics. This position presents a remarkable opportunity to enhance your career in Engineering while playing a vital role in the manufacturing of advanced CAR-T therapies. As a Process Engineering Specialist, you will...


  • Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Company Overview:Aisin North Carolina Corporation is a leading automotive supplier dedicated to innovation and sustainability. We are committed to enhancing our products, our workforce, and our community.Position Summary:The Manufacturing Engineer will play a crucial role in providing engineering support across various manufacturing processes and equipment....


  • Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Company Overview:Aisin North Carolina Corporation is a leading Tier 1 automotive manufacturer dedicated to innovation and excellence in the production of transmissions and components. Our commitment to quality extends to our team members, the community, and the environment.Position Overview:The Manufacturing Engineer will play a crucial role in providing...


  • Durham, North Carolina, United States PowerSecure, Inc. Full time

    Job OverviewPosition Summary:The Electrical Controls Engineer II is responsible for delivering electrical and controls design solutions for enhancements in the electrical and controls framework of our product lines. This role also involves coordinating site-wide documentation as required for specific projects. The primary objective is to ensure that our...


  • Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Job OverviewAt Aisin North Carolina Corporation, we embrace the motto "We Shape the Future" as a guiding principle. Our dedication to innovation extends beyond our products to encompass our workforce, the community, and environmental stewardship.Aisin North Carolina is a prominent Tier 1 automotive supplier specializing in transmissions and components, with...


  • Durham, North Carolina, United States CARsgen Therapeutics Full time

    Join Our Innovative Team at CARsgen TherapeuticsWe are excited to announce an opening for a Process Engineering Specialist at CARsgen Therapeutics. This position presents a remarkable opportunity to enhance your professional journey in Engineering and Maintenance while playing a vital role in the development of advanced CAR-T therapy manufacturing. In this...


  • Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Company Overview:Aisin North Carolina Corporation is a leading Tier 1 automotive manufacturer dedicated to innovation and excellence in the production of transmissions and components. Our commitment to sustainability and community engagement drives our operations.Position Summary:The Manufacturing Engineer will play a crucial role in enhancing manufacturing...


  • Durham, North Carolina, United States KBI Biopharma Full time

    Job SummaryThe Manufacturing Associate I/II - Downstream Process Specialist will be responsible for the execution of production activities for early and late-phase Cell Culture programs within a Good Manufacturing Practices (GMP) environment. This role will involve the execution of purification activities, including cell culture clarification, chromatography...