Vaccine Manufacturing Fermentation Engineer

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The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES
  • Participates in bioprocessing scale-up and technology transfer of Upstream processes (microbial and mammalian cultures)
  • Troubleshoots problems, analyzing situations and data with in-depth evaluation of various factors
  • Authors and revises documents (MBR's and SOP's) for upstream processes and equipment
  • Performs root cause analysis for deviations, and defines corrective and preventive actions for potential improvements
  • Provides process and equipment training for manufacturing associates
  • Provides support for QA and Regulatory for investigations and audits
  • Reviews documents for regulatory submissions
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria
  • Support FAT, SAT and validation activities
  • Evaluate new technology and provide suggestions for improvement of manufacturing processes
  • Will work with government process development scientists in the performance of assigned duties and will be responsible for ongoing communications to working groups and project teams

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of five (5) years of progressively responsible job-related experience in a pharmaceutical cGMP environment
  • Experience in working and troubleshooting of stainless steel and single use bioreactors
  • Hands-on experience in mammalian and microbial processes and prior experience in process scale-up and tech-transfer
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Master's degree in biochemical engineering or related field
  • Engineering analysis of bioprocessing methods; may include a specialty in downstream purification (e.g., filtration, ultrafiltration, chromatography separations, system programming) or bioreactor cell culture/fermentation (e.g., cell expansion, bioreactor control and analysis, centrifugation and depth filtration for clarification)
  • Experience in leading cross-functional and departmental meetings
  • Experience using Rockwell automation software

JOB HAZARDS OR REQUIREMENTS
  • Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)