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GMP ENGINEERING TECH, SR

Job Title: GMP ENGINEERING TECH, SR
Job Code: 2999
FLSA: E
Job Level: 71
Revised Date: 02/01/2022
Job Family: JF 05

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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 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 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). Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc). 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 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.

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 masters degree may substitute for two years of required experience.

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.


The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


Duke University 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 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.