GMP ENGINEERING TECH, SR

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home 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 Engineering Technician located in their Carolinas Cord Blood Bank Lab operations located at2400 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

This position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. Alternatively, will be responsible for supporting the daily engineering and facility operation of the GMP CCBB Laboratory facility to ensure it is in control and in compliance with applicable regulations. 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 GMP (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 refrigerators, 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 system administrator services for the environmental monitoring system including access point, collection point and sensor replacement, as needed. Respond to alarms and troubleshoot as appropriate.

Communicate changes to CCBB Lab Management.  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 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 all SOP and GMP guidelines.

Give guidance on cell manufacturing instrumentation operation including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets and CO2 gas system.

Accurately complete and review metrology documentation, all appropriate equipment log entries, and GMP documentation. Write and review validations, research plans and reports, SOPs, and batch records as required.

Maintain equipment calibration schedules and lab space, coordinating with contractors where required.

Work with Lab manager and quality assurance colleagues to ensure the facility is in compliance with governing regulations.

Participate in lab inspections and work with inspectors as needed.

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.

Training of new hires or lower-level manufacturing technicians.

Assure remedial action is taken and documented whenever test systems deviate from established performance specifications.

Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.

Preferred Skills:

Good communication skills and the ability to work independently as well as part of a 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.

Perform other related duties incidental to the work described herein.

Required Qualifications at this Level

Education/Training: 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 master's degree may substitute for two years of required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.