STERILIZATION VALIDATION / CQV ENGINEER

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Weil Group is seeking a Sterilization Validation/CQV Engineer to support development and execution of sterilization qualification activities involving autoclaves, SIP systems, thermometric studies, and Biological Indicators. You will coordinate with Manufacturing, Engineering, QC/Microbiology, and Quality to ensure compliant cycles and data integrity.

This role requires hands-on autoclave qualification, 5+ years of validation experience, and strong analytical skills to review temperature

Qualifications

• Bachelor's degree in Engineering, Microbiology, Biotechnology, Life Sciences, or related field.
• 5+ years of validation experience in pharma/biotech.
• 3+ years supporting sterilization validation activities.
• Hands-on autoclave qualification experience.
• Experience with thermometric studies and Biological Indicators.
• Knowledge of SIP systems and sterilization cycle parameters.

Responsibilities

• Develop and execute Sterilization PQ protocols.
• Prepare Sterilization PQ final reports.
• Review autoclave cycles and load configurations.
• Coordinate thermometric studies and Biological Indicators.
• Evaluate cycle parameters and lethality calculations.
• Support investigations of nonconforming results.
• Coordinate activities with Manufacturing, Engineering, QC/Microbiology, and Quality.
• Provide off-shift and weekend execution support as needed.

Skills

Sterilization validation

Autoclave qualification

Thermometric studies

Biological Indicators

SIP systems

Data analysis

Cross-functional coordination

Engineering mindset

Education

Bachelor's degree in Engineering, Microbiology, Biotechnology, Life Sciences, or related field

Tools

PI Historian

Job description

Position Summary

The Sterilization Validation/CQV Engineer will support development and execution of sterilization qualification activities involving autoclaves, SIP systems, thermometric studies, Biological Indicators, and associated sterilization cycles.

Key Responsibilities

• Develop and execute Sterilization PQ protocols.
• Prepare the corresponding Sterilization PQ final reports.
• Review existing and new autoclave cycles and load configurations.
• Support the qualification of new or modified sterilization cycles.
• Coordinate thermometric studies, including thermocouple and Biological Indicator placement and retrieval.
• Review temperature profiles, exposure times, lethality calculations, and other applicable cycle parameters.
• Evaluate sterilization cycle results against approved protocol acceptance criteria.
• Support sterilization conditional release activities as required.
• Review SIP cycles, when applicable.
• Generate and review PI Historian trends.
• Identify and communicate any nonconforming or unexpected sterilization results.
• Support investigations and technical assessments related to execution issues or discrepancies.
• Coordinate execution activities with Manufacturing, Engineering, QC/Microbiology, and Quality.
• Provide execution support during off-shifts, weekends, and extended-hour activities based on project needs.
• Review sterilization calculations, data, and execution results as required.

Minimum Recommended Qualifications

• Bachelor's degree in Engineering, Microbiology, Biotechnology, Life Sciences, or a related field.
• At least 5 years of experience in validation within the pharmaceutical or biotechnology industry.
• At least 3 years of experience supporting sterilization validation activities.
• Hands‑on experience with autoclave qualification.
• Experience with thermometric studies and the use of Biological Indicators.
• Knowledge of SIP systems and sterilization cycle parameters.

Weil Group is proud to be an Equal Employment Opportunity Employer.