Senior Electrical Equipment Technician
hace 6 días
Durham
Job Description DEPARTMENT: Site Operations; Engineering and Facilities 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 HAVs, 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit . JOB SUMMARY: The Senior Electrical Equipment Technician supports the Bioprocessing area by providing equipment technical support, equipment modifications, troubleshooting repairs and preventive maintenance support for specialized Bioprocessing equipment. This role will work closely with the Technical Operations, MSAT, Facilities and Metrology groups focusing on the electrical and electronics aspects of the bioprocessing equipment to ensure it operates efficiently, safely, and compliantly. The Senior Electrical Equipment Technician will ensure communication and strong coordination with the Lead Equipment Engineer, Bioprocessing, and all supporting departments. RESPONSIBILITIES: • Provides advanced electrical and electronics support for maintaining the equipment in the bioprocessing areas including troubleshooting, performing repairs, completing upgrades, and completing preventive maintenance tasks and calibrations., • Supports the execution of commercial manufacturing campaigns by ensuring all bioprocessing equipment operates reliably, safely and compliantly., • Works closely with the Lead Equipment Engineer to ensure the equipment in the bioprocessing area is operational and compliant., • Provides guidance of the bioprocessing process to others including a strong understanding of the impact of any process changes or improvements, as well as the impact of any process deviations., • Proactively identifies technical issues on bioprocessing equipment and recommends activities for resolution. Implements procedures and activities to prevent the same issues from occurring., • Authorize SOPs, reports, and protocols and solicit next level manager approval for final documents., • Provides daily technical floor support for clinical and/or commercial manufacturing operations., • Interfaces with the Manufacturing Operations and Manufacturing Science and Technology (MSAT) teams., • Recognizes and solves typical problems that occur in own work area without supervisory approval., • Supports the collection and tracking of area metrics and process control data., • Adheres to the proper handling of chemically hazardous goods., • Interfaces with process automation and electronic business systems., • Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation., • Trains other team members as needed., • Ensures Humacyte or other required trainings/certifications are up to date., • Other duties, as assigned. SPECIAL COMPETENCIES: • Advanced knowledge of bioprocessing processes including equipment such as incubators, bioreactors, TCU’s, refrigerators, and freezers and can identify potential problems before they occur., • Strong knowledge in electrical and electronics experience to help with troubleshooting bioprocessing equipment., • Experience in mechanical and refrigeration trouble shooting preferred., • Works within clearly defined standard operating procedures (SOPs) and/or scientific methods., • Attempts to solve problems before seeking support from management., • Has ability to differentiate between important and less important tasks within own work and act accordingly., • Strong and proactive communicator that is able to interface effectively across multiple departments with support as needed. GENERAL COMPETENCIES: • Able to communicate effectively in English, both verbally and in writing., • 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 collaborate effectively with others., • Excellent organizational and time management skills with ability to set own priorities in a timely manner., • High degree of flexibility and adaptability., • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook, • Must be able to work as needed to meet tight deadlines and at peak periods., • Self-motivated and organized critical thinker with solid interpersonal and business communication skills., • Demonstrated ability to work in a cross-functional team environment., • Adheres to company and facility specific policies and procedures, including SOP, training, and meeting requirements., • Ensures Humacyte or other required trainings/certifications are up to date., • Represents the organization in a positive and professional manner., • Reports to work on time and as scheduled. QUALIFICATIONS: • AAS in Electrical or Electronics Engineering or other relevant discipline required., • 4+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required., • Background in metrology, facilities and engineering necessary to troubleshoot and modify bioprocessing equipment in a cleanroom environment., • Strong electrical or electronics aptitude., • Works well in a team environment., • Strong experience working cross functionally within a BioPharma Bioprocessing organization., • Basic knowledge of cGMP requirements, required., • Experience executing SOPs and documenting work, required., • Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines., • 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 holidays, weekends, and over-time. HIGHLIGHTED PERKS & BENEFITS: • Stock Options, • 401k Plan with 4% Match and no Vesting Schedule, • Strong and competitive Medical, Vision and Dental Plans, • Company Paid Long Term/Short Term Disability, • Company Paid Life Insurance, • 23 Days Paid Time Off (PTO) to start., • 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 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.