GMP Technical Operations Equipment & Maintenance Lead Engineer - 168140

Summary

This position is responsible for assisting the Director of GMP Bioprocess Technology Manufacturing Operations for the Duke Human Vaccine Institute (DHVI) to develop, implement and oversee equipment and facility maintenance management deliverables for multiple cGMP manufacturing facilities; coordinate planning of cGMP cell bank, drug substance, and drug product clinical manufacturing equipment/facility deliverables; and develop/deploy/maintain standard work and systems for proactive predictive key performance indicators to prevent equipment/facility disruptions in support of early phase cGMP manufacture of materials for use in human clinical trials of HIV-1 and other infectious disease candidate vaccines.  This position will be lead all various aspects of cGMP equipment and facility maintenance required to support a large portfolio of products. 

Responsibilities

• Collaborates closely with Operations/Quality/Analytical Development/Portfolio management teams to provide support for cGMP manufacturing activities and works to learn the technical details of the cGMP facilities equipment, maintenance, and systems.
• Maintains all equipment and facilities required for cGMP production, including working with vendors to meet DHVI maintenance/budgetary/documentation needs, performs investigations which include authorship of detailed reports, compiling trends/risks/and recommendations to wider cGMP team / Quality, and negotiates pricing. This includes developing/deploying/maintaining systems to manages equipment/facility portfolios for all cGMP spaces (manufacturing, support, and analytical).   Maintains cGMP equipment and facilities on a daily/weekly/monthly/quarterly basis, including working with vendors to meet DHVI calibration/repair/documentation needs, execute cGMP activities such as cleanroom cleaning and certifications, performs investigations, and negotiates pricing. 
• Designs standard work, executes and documents cGMP activities in compliance with regulatory requirements.  Performs routine reporting of the state of the business to internal stakeholders (weekly facility schedules / shutdown plans / alarm trends, etc). 
• Manages winter and summer shutdowns for multiple cGMP facilities, inclusive of quote negotiation, purchase order submission, scheduling with vendors, oversight of execution, and close-out of records.  Provides start-up and on-going task execution, including commissioning / qualification / protocol documentation ownership and support, for cGMP facilities for equipment and systems items, such as processing equipment, critical utilities, and facility infrastructure.  Manages timelines and all deliverables included in this scope, such as SOP authorship, qualification requirements, tracking of issues/resolution, and turnover change control documentation closure.
• Writes and reviews technical reports; writes protocols for equipment / system validation and SOPs for cGMP systems, and presents data to project teams / external stakeholders / sister cGMP units at Duke.  Participates in facility audit readiness, hosts tours, and maintains a state of compliance for all facilities / systems / equipment at all times. 
• Compiles data, performs analysis / interpretation, and draws conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarizes data, presents results and proposes next steps to advance the cGMP program.
• Performs root cause analysis for all investigations and implements robust corrective actions in a timely manner.  Uses good documentation practices for all records, adhering to SOPs, and performing self-audits to ensure compliance.  Trains the broader cGMP team and vendors on proper equipment/facility management practices and acceptable corrective actions for a cGMP compliant organization. 
• 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. 

Education, Skills, & Experience Requirements

• Education: Bachelor's degree in a science, engineering, or related field. A Master's degree is preferred.
• Experience: 4 years relevant experience in the biopharmaceutical industry or equivalent.

Preferred Experience:

• Preferred experience that include the following:
  • Experience with facility and equipment maintenance planning
  • Hands-on maintenance experience with the execution of maintenance duties
  • cGMP Vaccine and/or Biologics manufacturing experience (clinical manufacturing and/or licensed product manufacturing)
  • Experience with cGMP Cell Banks and/or Drug Substance and/or Drug Product manufacturing (clinical manufacturing and/or licensed product manufacturing)
  • Solid understanding of cGMP regulations for Vaccines and/or Biologics
• Direct experience working with third-party vendors
• cGMP Facility and/or equipment start-up experience
• Master’s degree is a plus