Validation Specialist III

3 weeks ago


Swiftwater, United States The Fountain Group Full time
Job Description:
  • Support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized to produce the vaccines and biologics manufactured onsite.
  • Write protocols, reports, procedures, and memos as needed to support viral vaccine drug substance manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs.
  • Support execution of development and validation related studies.
  • Input design space/ DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals and process control strategies.
  • Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
  • Provide technical assistance to manufacturing and quality operations for process troubleshooting improvement, technical transfer, and health authority inspections to achieving site metrics (+QDCI).
Qualifications:
  • Bachelor of Science or Master of Science in basic sciences, math, engineering, or pharmacy with 2+ years' experience or PHD with experience in process validation is required.
  • Prior work experience with process validation and qualification is required.
  • Product development experience is highly desirable.
  • Prior working experience with drug substance, cell culture, downstream/upstream purification is highly desirable.
  • Prior working experience in a GMP environment is required.


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