CMMS Administrator na 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:

CMMS Administrator is responsible for managing and maintaining the CMMS systems used for the scheduling of work for calibration/PM and Spare Parts for all Humacyte departments. This position will be responsible for the continuous compliance of Humacyte’s CMMS systems with applicable corporate, local, and federal requirements, ensuring projects and facilities are maintained to cGMP standards by quickly and effectively taking appropriate actions when non-conformances are discovered. Position reports to Sr. Director, Engineering and Site Operations and will support all Facility, Maintenance, and Site Operations departments.

ESSENTIAL FUNCTIONS:

• Responsible for implementation, maintenance, and continued development of Humacyte CMMS systems. This will also include analyzing system performance, managing user accounts, resolving issues, and performing training
• Govern the entry and integrity of the Computerized Maintenance Management System and Honeywell Data Logger System
• Collaborate cross functionally to always ensure strict compliance with CMMS CGMP/GLP guidelines
• Research and provide informed recommendations for spare parts and PM job plans
• Manage the process and approval of change requests and enrollment forms for asset, maintenance, calibration, PM and spare parts by updating the CMMS for asset on-boarding
• Collect and input information in CMMS systems, including, but not limited to: manufacturer, model, serial number, and system structure information
• Assign work orders and manage work orders in the CMMS to ensure proper creation, scheduling, planning, update and closure of work orders
• Manage and maintain accuracy of spare parts database by regularly collecting and inputting information, to include, but not limited to; supplier, catalog number, min/max quantities, pricing, manufacturer, part numbers and current inventory
• Assist in the training and onboarding of all facility team members in the CMMS systems
• Prepare Calibration and PM work schedules by ensuring assets and schedule maintenance is documented in accordance with SOP guidelines, is consistent with management expectations, and uses facts/data to prepare for Calibration / PM meetings with the leadership team
• Measure and assist with reporting of KPI metrics daily/weekly by improving processes, helping interpret facts and data, and by making sound recommendations based on quantitative and qualitative data
• Measure and publish departments KPI metrics to the management team; interpret data, troubleshoot process, and make recommendations based on findings
• Other duties, as assigned

EXPERIENCE & QUALIFICATIONS:

• Associates Degree in Engineering, Life Sciences or other related technical field, required. preferred, or equivalent military training
• 3+ year Data management and documentation, CMMS experience, required
• 3 years of applicable Metrology, Maintenance and Facility experience, required
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working a variety of shifts, holidays, weekends and over-time
• Advance understanding and application of instrument, equipment, calibration, and maintenance of various parameters in manufacturing, utilities, and laboratory environments within a cGMP Biotechnology / Pharmaceutical manufacturing environment.
• Understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction
• Proven knowledge of a Computerized Maintenance Management System (CMMS)
• Strong organizational and planning skills required
• Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others

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.