Sterilization Process Engineer

S4 Analytics LLC; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A medical device company is looking for a Sterilization Process Engineer to lead the validation of iHP/VHP sterilization systems in compliance with FDA and ISO standards. Candidates should have a Bachelor's degree in Engineering or Microbiology and over 5 years of experience in sterilization and process validation within a GMP-regulated environment. Strong technical writing skills and hands-on experience with sterilization techniques are required. This position is critical for ensuring product safety and compliance.

Qualifications

• 5+ years of experience in sterilization/process validation under GMP standards.
• Hands-on experience with iHP/VHP sterilization and enzymatic indicator monitoring.
• Strong technical writing and validation documentation skills.

Responsibilities

• Lead iHP/VHP sterilization system validation and process implementation.
• Conduct equipment qualification and cycle design.
• Ensure compliance with FDA and ISO standards.

Skills

Technical writing

Process validation

GMP knowledge

Sterilization techniques

Analytical skills

Education

Bachelor’s in Engineering, Microbiology, or related field

Job description

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