School of Medicine
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
The Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an immediate opportunity for a motivated individual to join their team as a Sr. GMP Facilities Engineering Technician in their GMP manufacturing operations located at 2400 Pratt Street, Durham, N.C.
MC3 Vision: To live in a world where every person has access to high quality and effective cell based therapies
MC3 Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health
Occupational Summary
The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. Alternatively, this individual will be responsible for supporting the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.
Work Performed
Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guideline. Following standard operating procedures, conduct facility and engineering operation and maintenance under GXP (GLP, GTP, GMP, GDP) guidelines.
Utilize metrology techniques to calibrate equipment parameters such as temperature, pressure, mass, humidity and pressure for controlled units such as refrigerator, freezers, and incubators. Maintain, troubleshoot, and repair/upgrade all Critical Systems Controls, equipment work orders, PM and calibration schedules. Conduct balance scale check and verification for the facility. Provide documentation to support measurements. Work with user teams to ensure tracking systems are working properly and provide accurate information.
Perform calibration utilizing metrology methods for Isensix environmental monitoring system. Perform repair and system administrator services to the Isensix environmental monitoring system including access point, collection point and sensor replacement.
Communicate changes to GMP Lab staff. Support personnel that come on site for equipment repairs or calibration (assist them with facility access and supervise gowning in). Coordinate and schedule calibration activities with laboratory and manufacturing departments to meet deadlines.
Assists with tasks for engineering department and manufacturing such as repairs, scheduling and shadowing vendors and contacting manufacturers for support. Manage spare parts and portable equipment inventory.
Apply Good Documentation Practices (GDP) for all records, adhering to SOPs, and verification to ensure compliance. Performs and documents all activities as outlined in applicable SOP and GMP guidelines.
Accurately complete and review metrology documentation, all appropriate equipment log entries, and GMP documentation. Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
Maintain sufficient inventory of supplies and reagents for performance of duties.
Provide guidance on and participate in cleaning and maintenance on laboratory equipment in good working order.
Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
Perform other related duties incidental to the work described herein.
Preferred Skills:
Good communication skills and the ability to work independently as well as part of team. Communicate and interact in a professional and courteous manner with co-workers, and others. Must be team oriented and able to work in a highly collaborative work environment to complete complex tasks. Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.
Minimum Qualifications
Education
Work requires a bachelor's degree in science, engineering, or related field.
Experience
Work requires a minimum of two years of laboratory experience, preferably in a GMP/regulated environment. A related masters degree may substitute for two years of required experience.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.