Sterilization Process Engineer
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 GMP
Hands‑on with iHP/VHP sterilization & EI monitoring
Knowledge of GMP, ISO 13485, 21 CFR Part 820
Strong technical writing & validation documentation skills
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