Validation Specialist III - The Fountain Group

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.