Sterilizer & Autoclave Qualification Engineer

Veg Group; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking an experienced Sterilizer/Autoclave Qualification Engineer to support IQ, OQ, PQ, and cycle development in a GMP microbiology lab environment.

You will develop and execute qualification protocols, document results, analyze data, and prepare comprehensive reports while verifying installation, controls, and heat transfer performance. This role requires coordinating load configurations and ensuring acceptance criteria are met.

Qualifications

• Experience with IQ, OQ, and PQ protocols in a GMP lab.
• Strong knowledge of heat distribution and heat penetration studies.
• Ability to document discrepancies and prepare qualification reports.
• Experience with sterilization cycle development and pre-vacuum testing.
• Proven data analysis and report generation skills.

Responsibilities

• Develop, review, and execute IQ, OQ, and PQ protocols for sterilization equipment.
• Verify installation, utilities, components, materials of construction, documentation, and calibration status.
• Execute and document OQ testing: operating ranges, temperature and pressure controls, timers and cycle programming, alarms and interlocks, emergency functions, sensor operation, data recording, user access, audit trails and report generation, power-failure response, cycle abort and recovery functions.
• Support vacuum leak testing and Bowie-Dick testing for pre-vacuum cycles.
• Execute loaded heat distribution and heat penetration studies.
• Establish thermocouple, biological indicator, and chemical indicator locations; perform F0 calculations for liquid loads.
• Evaluate biological and chemical indicator results for pre-vacuum loads.
• Verify sterilization cycles meet acceptance criteria; perform PQ runs.
• Prepare and execute qualification documentation: IQ/OQ/PQ protocols and test sheets; load maps; indicator documentation; discrepancy resolution; IQ/OQ/PQ reports.

Skills

Sterilizer qualification

IQ/OQ/PQ protocols

Heat distribution

Thermocouples

Data analysis

Documentation

Cycle development

GMP environment

Tools

Data loggers

Thermocouples

Job description

Validation & Engineering Group, Inc. is seeking an experienced Sterilizer/Autoclave Qualification Engineer to support IQ, OQ, PQ, and cycle development in a GMP microbiology lab environment.

You will develop and execute qualification protocols, document results, analyze data, and prepare comprehensive reports while verifying installation, controls, and heat transfer performance. This role requires coordinating load configurations and ensuring acceptance criteria are met.