CQV Engineer

Location: South Chicago, United States; travel to client sites is required as needed.

Company

hirify.global provides commissioning, qualification, validation, and other compliance services for regulated life sciences organizations.

What you will do

• Develop, review, and execute commissioning, qualification, and validation documentation for facilities, utilities, equipment, and manufacturing systems.
• Author and execute Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports.
• Support system walkdowns, punch-list resolution, turnover packages, startup activities, and project execution.
• Qualify HVAC, clean steam, purified water, WFI, compressed gases, CIP/SIP systems, process equipment, and cleanroom environments.
• Conduct risk assessments, traceability activities, discrepancy investigations, deviation resolution, CAPA support, and change control assessments.
• Coordinate with Engineering, Manufacturing, Quality Assurance, Automation, Facilities, and client project teams.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• Experience with commissioning, qualification, and validation in pharmaceutical, biotechnology, medical device, or related regulated industries.
• Working knowledge of cGMP regulations, industry guidance, risk-based validation, and lifecycle approaches.
• Experience with IQ/OQ/PQ protocols, validation reports, manufacturing equipment, process systems, clean utilities, facilities, or cleanrooms.
• Strong technical writing, documentation, communication, troubleshooting, analytical, and organizational skills.
• Must be authorized to work in the U.S.; C2C arrangements are not available.

Culture & Benefits

• Work with a global, multicultural team across strategically located offices.
• Access coaching, professional development, and tools for career growth.
• Compensation and benefits are provided as part of the employment offering.
• Equal employment opportunity applies to employees, interns, and applicants.