Senior Engineer, Validation Commissioning (Pharmaceutical Manufacturing)

Location: North Chicago, Illinois, United States

Salary: $84,500–$162,000 per year

Company

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

What you will do

• Develop User Requirements Specifications and Functional or Design Specifications for new and modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing with project engineers.
• Identify risk controls, critical elements, and equipment design traceability through FMEA and other risk assessments.
• Develop and execute commissioning, qualification, and validation protocols.
• Troubleshoot commissioning issues and document unresolved items.
• Support project leadership, operational procedures, staff training, equipment changes, and validation program risk management.

Requirements

• Bachelor's degree in engineering, science, or a related discipline, or equivalent technical experience.
• 6+ years of experience in manufacturing, quality, or engineering, including experience with at least four major validation subject areas.
• Experience developing commissioning, qualification, validation, risk management deliverables, specifications, and testing protocols suitable for regulatory review.
• Knowledge of quality and compliance management, including regulations and standards for API, bulk drug, or finished-goods manufacturing.
• Strong interpersonal, communication, negotiation, and teamwork skills, with the ability to manage five or more projects simultaneously.
• Ability to supervise junior or contract team members and qualification as a QRM facilitator appropriate to the role.

Nice to have

• Technical experience in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries.
• Prior supervisory experience.
• Three or more years of significant engineering or operational experience.

Culture & Benefits

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