What are the responsibilities and job description for the Senior Process Engineer position at HUMACYTE GLOBAL INC?
Job Description
Job Description
DEPARTMENT : MSAT
LOCATION : Durham, NC; Onsite / Not Remote
COMPANY : Humacyte Inc (Nasdaq : HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass graft, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.
JOB SUMMARY :
The Senior Process Engineer will provide engineering expertise in Bioprocessing manufacturing equipment and systems to support manufacturing operations with limited supervision and guidance. The primary duties of this position will be executing equipment checks, engineering tests, and troubleshooting activities to evaluate instrument / equipment performance, capabilities, issues, optimizations, and improvements within applicable procedures. This role will collaborate effectively with personnel in Manufacturing, Facilities & Engineering, Metrology, Validation, and Quality Assurance and utilize strong communication, technical expertise and influencing skills to generate optimal results.
ESSENTIAL FUNCTIONS :
- Serves as the engineering expert in HAV production systems; able to fully understand the manufacturing process, automation and engineering controls, to proactively consider solutions to potential problems
- Leads and performs hands-on testing / troubleshooting for advanced corrective / preventative maintenance and optimization of HAV manufacturing equipment, control systems, and instrumentation
- Schedule equipment checks and maintenance activities for Bioprocessing equipment with the equipment / area owners to ensure production schedules are maintained
- Drafts corrective and preventative maintenance work instructions for Bioprocessing equipment
- Investigate, identify root cause, and identify CAPA for bioprocessing deviations related to equipment performance
- Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
- Work with equipment manufacturers to procure repairs, spare parts and scheduled maintenance of HAV manufacturing systems and equipment
- Document work utilizing site’s Computerized Maintenance Management System (CMMS)
- Assist in equipment selection, qualification, and start up activities.
- Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
- For new equipment, is responsible for ensuring that the design requirements align with process, user, and functional requirements
- For new equipment, may participate and / or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), and Design Qualifications
- Collaborate as reviewer or approver of Validation protocols for equipment commissioning operations and equipment functional specifications created by Automation.
- Other duties, as assigned
EXPERIENCE & QUALIFICATIONS :
COMPENSATION & BENEFITS HIGHLIGHTS :
The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and / or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.
