Validation Engineer

Location: Onsite in Melrose Park, Illinois, United States. This is a full-time onsite role; weekends and off-shift hours may periodically be required. The position is not eligible for visa sponsorship now or in the future.

Salary: $65,000–$80,000 per year

Company

hirify.global provides a regulated manufacturing environment focused on compliant and reliable plant systems, equipment, and processes.

What you will do

• Provide technical support for initial validation and requalification of equipment, systems, and processes.
• Prepare, schedule, execute, and report on utility, equipment, cleaning, process, computer, and new-product validation studies.
• Program and operate analytical instruments, including temperature and humidity data loggers, for controlled-environment qualification.
• Schedule and perform HEPA filter and critical-area testing using smoke generators, photometers, velocity meters, and related equipment.
• Participate in teams responsible for specifying, installing, validating, troubleshooting, and maintaining systems, equipment, and processes.
• Improve validation programs in line with cGMPs, industry standards, change-control requirements, and quality systems.

Requirements

• Bachelor’s degree in a science or engineering field.
• At least one year of relevant experience in a cGMP-regulated industry.
• Experience preparing reports, deviations, or other technical documents.
• Knowledge of cGMPs, industry guidance, aseptic techniques, room classifications, HEPA testing, airflow-pattern testing, cleaning validation, process validation, and product validation.
• Understanding of statistical analysis, root-cause analysis, risk assessment, corrective and preventive actions, and investigation techniques.
• Effective spoken and written English is required; proficiency with Word, Excel, PowerPoint, Project, and Access is also required.

Nice to have

• Experience generating and executing Installation, Operational, and Performance Qualification protocols.
• Experience programming, operating, troubleshooting, and collecting data with analytical data loggers.

Culture & Benefits

• Medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, and personal days.
• Life insurance, disability coverage, employee assistance program, and wellness program.
• Work is performed in controlled plant areas, including Class 100, 10,000, and 100,000 environments; certification is required for entry.