Process Validation Scientist

2 weeks ago


Frederick, United States Kelly Science, Engineering, Technology & Telecom Full time

Process Validation Scientist


  • Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics
  • Lead Process Validation (Stage 3) activities including:
  • Process validation strategies, protocols/reports review/approval timely generation of Chemistry Manufacturing and Controls (CMC) documentation
  • Collaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Quality provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
  • Process investigation PV impact assessment strategies
  • Collaborate with global process validation team
  • Communicate CPV trends to Quality Management and CMC teams.
  • Present/defend process validation packages and strategies during audits and inspections.
  • Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data

Essential for the role:

  • Bachelor’s Degree preferably in Science or Engineering. Master’s Degree or PhD preferred.
  • At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.
  • Comprehensive knowledge PPQ and CPV regulatory expectations.
  • Fundamental understanding of upstream and downstream process units for biopharmaceutical products.
  • Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Process Validation/Process Performance Qualification
  • Knowledge of GMP manufacturing principles and documentation
  • Proficient in statistical tools and techniques commonly used in the Biotech industry.
  • Ability to apply critical thinking to solve problems and work independently
  • Strong interpersonal and communication skills.



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