Autoclave & Sterilization Engineer

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

Job Title: Autoclave & Sterilization Engineer

Employment Type: Contract through ProQuality Network

Schedule: Onsite role on administrative shift with flexibility to work shifts as needed

Position Summary

ProQuality Network is seeking a highly skilled Autoclave & Sterilization Validation Specialist for a contract assignment at our client’s site. This role requires deep technical expertise in steam sterilization processes, validation lifecycle execution, and sterilization science within an FDA-regulated environment.

The selected professional will execute validation activities, provide technical leadership on sterilization strategies, and ensure compliance with cGMP standards and regulatory expectations. Flexibility to work different shifts based on project needs is required.

Key Responsibilities

• Lead execution of steam sterilization cycle development, validation, and optimization activities
• Develop and justify load configurations, including worst-case rationale and documentation
• Perform and document F₀ calculations and lethality assessments
• Author, review, and approve URS, FS, and DS documentation related to sterilization systems
• Execute and document IQ, OQ, and PQ protocols for autoclaves and sterilization equipment
• Conduct empty chamber studies, heat distribution, and heat penetration studies
• Design and implement Biological Indicator (BI) and Chemical Indicator (CI) strategies
• Perform load mapping and worst-case load identification
• Conduct temperature mapping, including thermocouple (TC) placement and calibration verification
• Evaluate and document Sterility Assurance Level (SAL 10⁻⁶) compliance
• Apply D-value, Z-value, and bioburden-based sterilization approaches
• Select, place, and manage incubation of Biological Indicators
• Assess change impacts and execute requalification activities
• Lead technical remediation activities following failed PQ studies or regulatory observations

Required Qualifications

• Bachelor’s degree in Engineering (preferred Mechanical Engineers)
• Demonstrated hands-on experience with steam sterilization validation in regulated industries (pharmaceutical, biotechnology, or medical device)
• Strong knowledge of cGMP, sterilization science, and validation lifecycle requirements
• Proven experience executing and documenting sterilization validation studies independently
• Ability to work onsite with schedule flexibility based on operational needs