Engineer, Validation Commissioning (Pharmaceutical Manufacturing)

Location: North Chicago, Illinois, United States

Salary: $65,500–$125,500 annually

Company

hirify.global develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Develop User Requirements Specifications and Functional/Design Specifications for facilities, utilities, HVAC, and automated systems.
• Support Factory Acceptance Testing and verification activities before site deployment.
• Identify critical elements, risk controls, and requirements traceability using FMEA and other risk assessment methods.
• Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC, and environmental monitoring systems.
• Troubleshoot commissioning issues involving control logic, integration, instrumentation, documentation, and qualification deliverables.
• Support project leadership, operational procedures, technical training, change impact assessments, and coordination with contract validation resources.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline, or equivalent technical experience.
• At least 1 year of significant engineering or operational experience desired; 2+ years in manufacturing, quality, or engineering preferred.
• Experience creating commissioning, qualification, validation, or risk management specifications and testing protocols.
• Computer System Validation (CSV) experience is required.
• Experience with automation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls is strongly preferred.
• Ability to manage at least three projects simultaneously and collaborate with junior and contract team members.

Nice to have

• Experience in pharmaceutical, medical device, laboratory diagnostics, healthcare, nutritional products, or similar industries.
• Knowledge of quality and compliance regulations for API, bulk drug, or finished goods manufacturing.
• Experience facilitating FMEA or Quality Risk Management activities.

Culture & Benefits

• Paid time off, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) plan for eligible employees.
• Eligibility for short-term incentive programs.
• Equal opportunity employment committed to integrity, innovation, and community service.