Find & Apply For Biomedical Equipment Technician Jobs in Huntersville, North Carolina

Responsibilities:

Work closely with Carolina BioOncology Institute and BioCytics departments to ensure that all devices and instruments related to patient care, research, and laboratories are installed, maintained, calibrated, and utilized efficiently and safely Perform troubleshooting and maintain repair services as needed Monthly monitoring, including environmental control, QC charting, maintenance worksheets/logs, cleaning logs, refrigerator / freezer temperature log Ensure instrument maintenance including calibration is completed according to requirements and schedule Ensure preventive maintenance is performed and documented appropriately. Ensure that QC and equipment are all current and in compliance with applicable regulatory agencies Perform activities related to the acquisition and implementation of new equipment, including analyzing requirements, developing specifications, evaluating new devices and systems, and executing IQ, OQ, PQ, and validation activities. Draft and update Equipment and HAL SOPs, forms, technical reports, and GLP/GMP documentation related to job functions in an updated electronic environment Serve as super user of equipment and environmental monitoring software systems Collaborate across departments to ensure organizational consistency, facilitate effective teamwork, and drive the adoption of best practices. Demonstrate technical and team leadership to effectively solve problems, escalating issues as appropriate while maintaining a solution-oriented approach focused on continuous quality improvement. Identify and communicate organization-wide performance improvement opportunities, performance gaps, and resource needs. Recommend, implement, and support improvements to processes and equipment to enhance efficiency, robustness, reliability, and overall quality. Maintain accurate and complete documentation, including training records, in accordance with company procedures. Document changes through the established Change Control process. Collaborate with cross-functional teams to develop and maintain dashboard-style key performance indicators (KPIs). Develop, update, and distribute monthly reports that accurately summarize organizational and departmental performance. Support and manage client needs, requests, and projects to ensure timely, effective, and high-quality service. Work closely with PhDs, cell processing staff and clinical research staff in support of an FDA IND submission of cellular therapy clinical trial protocols. Adhere to FDA standards of Good Manufacturing Process (GMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), and International Society of Cellular Therapy (ISCT) guidelines, best practices for cellular therapy products and applicable regulations Work effectively in compliance with American Association of Blood Banks (AABB) Accreditation Cellular Therapy Standards and Foundation for Accreditation of Cell Therapy (FACT) inspection for Immune Effector Cell Standards Accreditation Participate in meetings relevant to responsibilities Monitor utilization and yield operating levels for the production community and lead project efforts to maximize Overall Equipment Effectiveness (OEE) & cost reduction Perform other human applications lab and quality duties or projects as assigned

Qualifications:

Minimum of 3-5 years of experience maintaining, troubleshooting, repairing, and calibrating biomedical equipment in a healthcare, laboratory, research, or regulated environment Experience supporting GMP equipment lifecycle management, including commissioning, qualification, validation, change control, and periodic review, preferred Experience performing equipment qualification and validation activities, including

IQ/OQ/PQ

Experience with preventive maintenance, corrective maintenance, equipment inspections, and calibration programs Experience maintaining equipment documentation, maintenance records, and validation documentation in accordance with quality management system (QMS) requirements Experience evaluating, installing, and implementing new equipment and instrumentation Experience collaborating with cross-functional teams, vendors, and clients to resolve equipment-related issues and support operational objectives. Strong troubleshooting, analytical, organizational, and project management skills. Experience working within a regulated environment (e.g., GMP, GCP, GLP, CAP/CLIA, AABB, FACT, or FDA-regulated environment) preferred

Education Requirements:

Associate's or Bachelor's degree in Biomedical Equipment Technology or a related field, or equivalent combination of education and experience Certified Biomedical Equipment Technician (CBET) certification required

Work Location:

One location

Work Remotely:

No Job Type:

Full-time Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Are you willing to undergo a background check, in accordance with local law/regulations? Are you willing to take a drug test, in accordance with local law/regulations?

Education:

Associate (Required)

Experience:

biomedical equipment: 3 years (Required)

License/Certification:

Certified Biomedical Equipment Technician (CBET) (Required) Ability to

Commute:

Huntersville, NC 28078 (Required)

Work Location:

In person