Sterilizer / Autoclave Qualification Engineer

Pinnaql; Caguas (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group is seeking an experienced Sterilizer/Autoclave Qualification Engineer to support IQ, OQ, PQ of sterilization equipment in a GMP microbiology lab environment.

The role covers development, execution, data analysis, and reporting of qualification activities, including load configurations, validation protocols, and cycle validation to meet established acceptance criteria.

Qualifications

• Demonstrated experience with sterilizer/autoclave qualification in a GMP environment.
• Experience developing and executing IQ, OQ, and PQ protocols.
• Experience with sterilization cycle development.
• Knowledge of heat distribution and heat penetration studies.
• Experience with calibrated data-logger systems and thermocouples.
• Knowledge of F0 calculations and evaluation of liquid sterilization cycles.
• Experience with biological indicators and chemical indicators.
• Knowledge of pre-vacuum sterilization testing including vacuum leak and Bowie-Dick testing.

Responsibilities

• Develop, review, and execute IQ, OQ, and PQ protocols for sterilization equipment.
• Verify installation, utilities, components, materials of construction, documentation, and calibration status as part of IQ.
• Execute and document OQ testing: operating ranges, temperature/pressure controls, timers, alarms, safety functions, and data recording.

Skills

Sterilizer/Autoclave qualification

IQ/OQ/PQ protocols

Heat distribution studies

Thermocouples & data loggers

Qualification data analysis

Job description

Current job opportunities are posted here as they become available.

Sterilizer / Autoclave Qualification Engineer

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sterilizer / Autoclave Qualification Engineer

Position Summary

We are seeking an experienced Sterilizer / Autoclave Qualification Engineer to support the Installation Qualification (IQ), Operational Qualification (OQ), cycle development, and Performance Qualification (PQ) of a sterilizer used within a GMP microbiology laboratory environment.

The engineer will be responsible for the development, execution, documentation, data analysis, and reporting associated with sterilizer qualification activities. The scope includes verification of equipment installation and utilities, operational controls and safety functions, cycle development, heat distribution and heat penetration studies, and qualification of representative laboratory loads under routine operating conditions.

Key Responsibilities

• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterilization equipment.
• Verify equipment installation, utilities, components, materials of construction, documentation, and calibration status as part of IQ activities.
• Execute and document OQ testing of:
  • 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 and execute applicable vacuum leak testing and Bowie-Dick air-removal testing for pre-vacuum cycles.
• Execute loaded heat distribution and heat penetration studies.
• Establish and document thermocouple, biological indicator, and chemical indicator locations based on approved load configurations.
• Perform and document F0 calculations and evaluation for liquid sterilization loads.
• Evaluate biological and chemical indicator results for applicable pre-vacuum sterilization loads.
• Verify that sterilization cycles consistently meet established acceptance criteria.
• Performance Qualification Activities

The engineer will support qualification of four representative load families, evaluated at both maximum and minimum configurations:

• Liquid waste
• General dry laboratory materials
• Complex assemblies and tubing

The qualification strategy includes eight total PQ load configurations, representing maximum and minimum conditions for each load family.

Additional Responsibilities:

• Develop and verify approved load diagrams.
• Confirm maximum and minimum load configurations.
• Define equipment loading, orientation, shelf placement, and applicable container fill volumes.
• Establish worst-case thermocouple locations.
• Establish biological and chemical indicator locations.
• Execute three successful consecutive PQ runs per approved configuration.
• Support qualification of both liquid and pre-vacuum sterilization cycles.
• Evaluate worst-case steam penetration conditions for complex assemblies, tubing, hoses, manifolds, housings, and similar components.
• Document discrepancies identified during execution and support their investigation and resolution.

The engineer will be responsible for preparing and/or executing the qualification documentation required to support the complete sterilizer qualification package, including:

• IQ Protocol
• OQ Protocol
• PQ Protocol
• IQ/OQ/PQ test sheets
• Load mapsThermocouple location documentation
• Biological indicator location documentation
• Chemical indicator requirements
• Discrepancy documentation and resolution
• IQ Report
• OQ Report
• PQ Report

All studies must be supported by documented data analysis and summarized in approved qualification reports demonstrating compliance with established acceptance criteria.

Technical Experience & Skills

• Demonstrated experience with sterilizer/autoclave qualification in a GMP environment.
• Experience developing and executing IQ, OQ, and PQ protocols.
• Experience with sterilization cycle development.
• Knowledge of heat distribution and heat penetration studies.
• Experience working with calibrated data-logger systems and thermocouples.
• Knowledge of F0 calculations and evaluation of liquid sterilization cycles.
• Experience with biological indicators and chemical indicators.
• Knowledge of pre-vacuum sterilization testing, including vacuum leak and Bowie-Dick testing.
• Experience establishing and evaluating maximum/minimum and worst-case sterilization load configurations.
• Ability to analyze qualification data, document discrepancies, and prepare complete qualification reports.
• Strong documentation practices within a cGMP-regulated environment.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.