Duke Job Postings
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GMP ENGINEERING TECH
Job Title: GMP ENGINEERING TECH
Job Code: 0561
Job Level: 51
Revised Date: 02/01/2022
Job Family: JF 05
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 operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. An integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.
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.
Required Qualifications at this Level
Work generally requires a bachelor's degree in science, engineering, or related field.
None required above education/training requirement. Prefer up to two years of laboratory experience, preferably in a GMP/regulated environment.
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.
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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.