CQV Engineering

Job Title: CQV Engineering Location: Chicagoland, IL

Position Summary: We are actively hiring a motivated and detail-oriented individual to support engineering activities related to equipment, utilities, systems, and processes within a GMP-compliant manufacturing environment. This role offers an excellent opportunity for recent graduates to gain hands-on experience in Commissioning, Qualification, and Validation (CQV).

Key Responsibilities:

Assist in the setup, testing, and operation of new equipment and systems

Execute validation and qualification studies (utilities, equipment, cleaning, computer systems, etc.)

Prepare validation protocols and final reports

Operate temperature/humidity dataloggers for equipment qualifications (e.g., lyophilizers, sterilizers)

Support deviation investigations through data gathering and reporting

Collaborate with subject matter experts (SMEs) to resolve technical issues

Author standard operating procedures (SOPs) and update documentation as required

Ensure compliance with GMP standards, FDA regulations, and internal safety protocols

Requirements

• Bachelor’s degree in Engineering, Science, or a related field

• 5+ years of GMP experience (including internships or co-ops)

• Strong technical writing and documentation skills

• Familiarity with FDA regulations and current Good Manufacturing Practices (cGMP)

• Business minor or coursework is a plus

• Proficiency in Microsoft Word, Excel, and electronic documentation systems

• Excellent communication and problem-solving skills