Senior Pharmaceutical Equipment Validation Specialist

Employer
  • Accentuate Staffing

Job Description

Accentuate Staffing is currently recruiting an Validation Specialist to join a growing company in the Rocky Mount, NC area.

Responsibilities

  • Develop and execute Qualification deliverables for Terminal Sterilizers including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports

 

Requirements

  • Education: Bachelor’s degree in Engineering or related science studies.
  • Prefer five (5)+ years related work experience including strong knowledge and hands-on experience in the regulated industries.
  • Strong technical writing skills
  • Understanding and experience with regulations and guidelines such as USP and FDA related sterilization of filled flexible containers
  • Strong knowledge of P&IDs, wiring diagrams, and I/O testing
  • Strong knowledge and experience with thermal validation/temperature mapping and data analysis for sterilization cycles.
  • Knowledge of flexible container manufacturing processes a plus
more