Senior Process Engineer

Job DescriptionJob 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 in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, 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 has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. 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:

• Associate’s degree in engineering, Life Sciences or other related technical field, required. Bachelor’s Degree in Engineering, , or equivalent military training
• Requires at least 8 years of prior work experience in maintaining Bioprocessing production systems and equipment under cGMP regimen
• Hands-on troubleshooting and corrective action implementation with a broad range of Bioprocessing systems
• Experience directing work of trade personnel and/or outside contractors
• Experience in the installation and troubleshooting of complex Bioprocessing systems
• Strong experience working cross functionally within a BioPharma Bioprocessing organization
• Experience leading projects related to, process optimization, technical troubleshooting, and bioprocessing equipment changes
• Majority of work will be performed in clean room environment to provide process engineering assistance to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Highly motivated and organized
• Works and leads well in a team environment Experience with electrical, pneumatic, mechanical, and instrumentation; as well as manual and computer-based process control loops and systems required
• Excellent communication and interpersonal skills.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Represents the organization in a positive and highly professional manner.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

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 , , , , , , , Veterans status, and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.