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GMP OPERATIONS PROCESS ENGINEER

Req ID:  5539
Date:  Oct 21, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Summary

 

This position is responsible for assisting the Assistant Director of GMP Operations for the Duke Human Vaccine Institute (DHVI) to develop, implement and oversee operations management strategies to ensure CGMP-compliant clinical manufacturing facilities that supply and release early phase materials for use in human clinical trials of HIV-1 candidate vaccines.

 

Responsibilities

 

  • Manage all materials required for CGMP production, including working with vendors to meet DHVI shipping/delivery/documentation needs, performing investigations, and negotiating pricing.
  • Manage all CGMP equipment and facilities, including working with vendors to meet DHVI calibration/repair/documentation needs, performing investigations, and negotiating pricing.
  • Perform root cause analysis for all deviation investigations and implementing robust Corrective Action Preventative Action (CAPA) in a timely manner. 
  • Apply Good Documentation Practices (GDP) for all records, adhering to SOPs, and performing self-audits to ensure compliance.
  • Create visual management systems for mapping process and metrics to succinctly communicate material/equipment/facility status, plans, and risks.
  • Collaborate with team members to create and manage an operations schedule for materials/facilities/equipment/production logistics. 
  • Interface with regulatory agencies, as needed/upon request by management. 
  • Provide support for CGMP campaigns, including execution of unit operations and manufacturing process, as needed/upon request by management. 
  • Provide start-up assistance, as needed, including commissioning / qualification / protocol ownership and support, upon request by management. 
  • Create and deploy training/SOP/change control documentation, as needed, for area(s) of responsibility.    
  • Perform other related duties as necessary and requested by GMP leadership.

Work hours

You must be willing and available to work flexible hours which may include later start and end times with the understanding that work hours may need to be extended until a project/task has reached a logical and acceptable stopping point to maintain the integrity of the process.

 

Minimum Qualifications

 

 

Education

Bachelor's degree in a science, engineering, or related field

 

Preferred Experience

 

 

  • Preferred experience that include the following:
    • CGMP Vaccine and/or Biologics manufacturing experience (clinical manufacturing and/or licensed product manufacturing)
    • Solid understanding of CGMP regulations for Vaccines and/or Biologics
    • GDP experience in an agency-regulated manufacturing environment
    • Experience with visual management use and/or development
    • Experience authoring and/or approving controlled documents
  • Direct experience interfacing with CGMP regulatory agencies
  • CGMP Facility start-up experience
  • Direct experience working with third-party vendors

 

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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh