GMP Operations Process Engineer
GMP Operations Process Engineer
Duke Human Vaccine Institute - Admin
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 and projects 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.
- 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 related to the projects and implement 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.
- Oversee project planning/management and 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 projects/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.
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.
2822 PROJECT PLANNER II
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.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.
Bachelor's degree. Additional training in Project Management course work or certification in Project Management is desired.
Four years of progressively responsible experience in project management, including complex projects involving multiple functional groups. Experience in medical education/publishing, clinical research,or medical product development is desired.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.
- Bachelor's degree in relevant Science or Engineering field, Master's degree is a plus
- Must have a minimum of 4 years of relevant 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
- Must be detail-oriented, well organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment.
- Must have strong project planning and execution experience/skills
- Must have the ability to problem solve and operate independently
- Must demonstrate the highest degree of ethics and integrity at all times
- Direct experience interfacing with CGMP regulatory agencies
- CGMP Facility start-up experience
- Direct experience working with third-party vendors
- Certification in Project Management
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.