Sterilization Process Engineer
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Role Overview:
Seeking a Sterilization Process Engineer to lead iHP/VHP sterilization system validation and process implementation in a GMP-regulated medical device environment. Role includes cycle design, equipment qualification, enzymatic indicator (EI) validation, and compliance with FDA/ISO standards.
Key Requirements:
Bachelor’s in Engineering, Microbiology, or related field 5+ years in sterilization/process validation under GMPHands-on with iHP/VHP sterilization & EI monitoring Knowledge of GMP, ISO 13485, 21 CFR Part 820 Strong technical writing & validation documentation skills