Sterilization Validation Expert (Autoclave & Cycle)

ProQuality Network; United States; Hybrid; USD 96,000 - 165,000; Full time

Job summary

ProQuality Network is seeking an Autoclave & Sterilization Engineer for a contract assignment on site. The role focuses on steam sterilization validation, lifecycle execution, and regulatory compliance within an FDA-regulated setting.

You will lead validation activities, provide technical leadership on sterilization strategies, and ensure adherence to cGMP standards. The position requires hands-on experience, the ability to work onsite with flexibility for shift changes, and a strong background

Qualifications

• Hands-on steam sterilization validation experience in regulated industries.
• Strong knowledge of cGMP, sterilization science, and validation lifecycles.
• Ability to work onsite with schedule flexibility.

Responsibilities

• Lead execution of steam sterilization cycle development, validation, and optimization.
• Develop and justify load configurations with worst-case rationale.
• Perform and document F0 calculations and lethality assessments.
• Author, review, and approve URS, FS, and DS documentation for sterilization systems.
• Execute and document IQ, OQ, and PQ protocols for autoclaves and sterilization equipment.
• Conduct load mapping, heat distribution, and temperature mapping studies.
• Design and implement BI/CI strategies for sterilization validation.
• Evaluate SAL 10⁻⁶ compliance and bioburden considerations.
• Lead remediation activities after PQ deviations or regulatory observations.

Skills

Steam sterilization validation

Validation lifecycle

Sterilization science

cGMP compliance

F0 calculations

Lethality assessments

Indicator strategies

Temperature mapping

QA documentation

Education

Bachelor's degree in Engineering

Job description

ProQuality Network is seeking an Autoclave & Sterilization Engineer for a contract assignment on site. The role focuses on steam sterilization validation, lifecycle execution, and regulatory compliance within an FDA-regulated setting.

You will lead validation activities, provide technical leadership on sterilization strategies, and ensure adherence to cGMP standards. The position requires hands-on experience, the ability to work onsite with flexibility for shift changes, and a strong background