Autoclave & Sterilization Engineer
Job Title: Autoclave & Sterilization Engineer
Location: Onsite – Puerto Rico (Open for Puerto Rico Residents)
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
If you meet the qualifications and are interested in joining ProQuality Network as a contractor supporting our client’s operations, we invite you to apply through the job description link with your updated resume for immediate consideration.