Validation Engineer (Computer Systems)

Location: Melrose Park, IL, United States; full-time onsite position

Salary: $65,000–$80,000 per year

Company

hirify.global operates in the regulated healthcare and pharmaceutical manufacturing sector.

What you will do

• Schedule and execute computerized system qualifications, coordinate testing, evaluate results, and prepare final reports.
• Execute validation studies covering utilities, equipment, cleaning, processes, computer systems, and new products.
• Develop test scenarios, environments, and scripts for MES, electronic batch records, historian, and other manufacturing applications.
• Create and maintain lifecycle documentation, including user requirements, functional and design specifications, risk assessments, FMEAs, and qualification protocols.
• Support system specification, installation, validation, troubleshooting, investigations, change controls, and corrective or preventive actions.
• Develop validation master plans and project plans while maintaining alignment with cGMPs and industry standards.

Requirements

• Bachelor’s degree in science or engineering.
• At least one year of related experience in a cGMP facility, including FDA-regulated medical, drug, or device products.
• Experience generating and executing installation, operational, and performance qualification protocols.
• Knowledge of cGMPs, aseptic techniques, process and product validation, and industry guidance.
• Understanding of MES/EBR, historian, OEE, and other manufacturing applications.
• Effective spoken and written English is required for working with policies, procedures, training materials, and workplace communications.

Culture & Benefits

• Full-time employment with an onsite work arrangement.
• 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, and wellness programs.