Senior Pharmaceutical Equipment Validation Specialist
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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
