Sterilization Validation Engineer — Process Characterization

ProQuality Network; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Validation Engineer to support sterilization load validation and process characterization in a regulated manufacturing environment. You will design, execute, and report validation activities for autoclave cycles and related processes, ensuring GMP compliance.

The role requires 4+ years in validation engineering, experience with sterilization/cleaning validation, and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field; advanced degree preferred.
• 4+ years of validation engineering in regulated manufacturing (pharma/biotech/medical devices).
• Experience with GMP and validation lifecycle documentation.
• Experience with sterilization and cleaning validation; equipment qualification.
• Ability to troubleshoot complex validation issues and interpret data.
• Experience in Puerto Rico’s pharmaceutical/biotech industry desirable.

Responsibilities

• Develop, execute, and report validation protocols for sterilization loads and autoclaves.
• Design and characterize autoclave/cleaning cycles for process tools and components.
• Coordinate testing with manufacturing, quality, and labs.
• Access and manage data using systems such as LIMS and PI-Historian for documentation and trending.
• Prepare and submit validation reports and supporting documentation packages.
• Support SOP and batch record updates for validated processes.
• Collaborate across cross-functional teams to align with schedules and regulatory expectations.
• Provide training and technical guidance to personnel as needed.
• Work evenings/weekends/holidays as required to support validation execution.

Skills

Sterilization validation

Cleaning validation

Equipment qualification

GMP compliance

Cross-functional collaboration

Troubleshooting

Education

Bachelor’s degree in Engineering/Science

Tools

LIMS

PI-Historian

Job description

ProQuality Network seeks a Validation Engineer to support sterilization load validation and process characterization in a regulated manufacturing environment. You will design, execute, and report validation activities for autoclave cycles and related processes, ensuring GMP compliance.

The role requires 4+ years in validation engineering, experience with sterilization/cleaning validation, and cross-functional collaboration.