Senior Mechanical Technician en Humacyte Inc

DEPARTMENT: Site Operations

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 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 received the RMAT designation. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Senior Mechanical Technician must have a range of relevant experience in electrical and mechanical as well as controls and instrumentation maintenance services to assure Overall Equipment Effectiveness (OEE). The successful candidate will assist in developing and implementing routine preventive and predictive maintenance programs and tasks. The candidate will be responsible for day-to-day operations of the facility including utilities, facilities, production, lab and office spaces and all associated equipment. The candidate will be a key contributor in keeping the site and its assets available and ready to meet Humacyte’s objectives.

ESSENTIAL RESPONSIBILITIES:

• Executes the goals and objectives for the department set by the Sr. Manager of Maintenance and Clean Utilities and other departmental leaders.
• Perform planned and corrective maintenance of central utility and clean utilities systems.  These systems and equipment could include areas of research, process development and bioprocessing.
• Prioritize workload to maintain a compliant and safe work environment while completing tasks in a timely manner.
• Develop and review maintenance SOPs, work instructions, preventative and predictive maintenance programs, job plans, spare parts lists, risk assessments, and reports.
• Able to document all equipment work and repairs in equipment logbooks providing necessary information to meet GMP requirements. 
• Administer maintenance records and coordinates required training to contractors as needed.
• Document work utilizing site’s Computerized Maintenance Management System (CMMS)
• Work with equipment manufacturers to procure repairs, spare parts and scheduled maintenance of systems and equipment.
• Schedule maintenance activities with the equipment/area owners to ensure production schedules are maintained.
• Work closely with area owners and department managers to coordinate maintenance events to include planning for preventative and corrective maintenance.
• Work to maintain maintenance metrics as developed by department managers.
• Ensure all Facilities, Utilities and Maintenance operations comply with all EHS policies and regulations such as Lock-Out/Tag-Out, use of Personal Protective Equipment
• Ensure the uninterrupted delivery of critical utilities including HVAC, electrical distribution, compressed air, process gasses, chilled water, and steam to site customers.
• Monitor and troubleshoot Building Automation Systems (BAS) in support of 24/7 operations.
• Other duties, as assigned

EXPERIENCE & QUALIFICATIONS:

• High School Diploma or GED, required.  Associate or Bachelor’s degree in Engineering, Electrical or Applied Engineering, preferred
• Requires at least 6 years of prior work experience in maintaining facility support systems and equipment under cGMP regimen.
• Hands-on troubleshooting and corrective action implementation with a broad range of mechanical and electrical systems
• Experience directing work of trade personnel and/or outside contractors.
• Experience in the installation and troubleshooting of complex mechanical production systems.
• Experience in safely working with single and 3-phase equipment. 
• Experience with routine preventive maintenance and troubleshooting of mechanical facilities equipment and clean utilities systems.
• Will spend a portion of time in clean room environment to provide facilities assistance to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines. 
• Ability to lift and carry up to 40 lbs., standing for extended periods of time, work from ladders.
• Position may require working holidays, weekends and over-time.
• This position is designated as essential.
• This position will require being on-call in a rotation with other team members

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 Disability
• 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 3^rd 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 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.