Utility Validation Engineer

cGMP Consulting Inc.; Melrose Park (IL); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401K

Job summary

cGMP Consulting is seeking a motivated, mid-level professional to lead utility system validation and qualification activities within a GMP manufacturing environment. This role offers leadership and responsibility for qualification projects from planning through execution, with collaboration across engineering and operations.

The ideal candidate will have strong understanding of cGMP and FDA guidelines and hands-on IQ/OQ/PQ experience for WFI and purified water systems, plus lead roles in

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 2–5 years’ experience validating GMP utility systems and associated instrumentation.
• 2–5 years in GMP manufacturing, drafting SOPs, protocols, and reports; FDA familiarity.
• Strong writing, organizational, and interpersonal skills.

Responsibilities

• Author specifications and supporting documentation (URS, RA, FS) for utility systems.
• Lead equipment commissioning testing in collaboration with Engineering for utility systems.
• Develop and execute qualification protocols (IQ/OQ/PQ) for GMP-critical utility systems, including WFI and Purified Water systems.
• Lead qualification of clean steam, compressed air, and process gas systems, including protocol development, execution, and reporting.
• Perform temperature mapping and static/dynamic airflow and smoke studies to support HVAC system and cleanroom qualification.
• Manage multiple qualification activities while providing deliverable updates and modifications to scheduling.
• Lead cross-functional team meetings, prepare agendas and document meeting notes.
• Assist in project forecasting and plan requirements for upcoming tasks.
• Collaborate with process experts to identify and resolve technical challenges.
• Provide technical expertise and recommend process improvements.
• Maintain compliance with company policies, cGMP standards, and safety protocols.

Skills

GMP compliance

Regulatory knowledge

Technical writing

Project leadership

Education

Bachelor's degree in Engineering/Science

Tools

Kaye Validators

Dataloggers

Job description

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.

Position Summary

cGMP Consulting is seeking a motivated and detail-oriented individual to lead utility system validation and qualification activities within a GMP-compliant manufacturing environment. This mid-level role offers leadership and responsibility for qualification projects from planning through execution. The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and protocol completion while demonstrating independence. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Responsibilities

• Author specifications and supporting documentation (URS, RA, FS) for utility systems
• Lead equipment commissioning testing in collaboration with Engineering for utility systems
• Develop and execute qualification protocols (IQ/OQ/PQ) for GMP-critical utility systems, including Water for Injection (WFI) and Purified Water systems, to ensure consistent compliance with regulatory and pharmacopeial standards
• Lead qualification of clean steam, compressed air, and process gas systems, including protocol development, execution, and reporting
• Perform temperature mapping and static/dynamic airflow and smoke studies to support HVAC system and cleanroom qualification, using Kaye Validators and other analytical instrumentation (e.g., temperature/humidity dataloggers)
• Manage multiple qualification activities while providing deliverable updates and modifications to existing scheduling to support execution activities
• Lead cross-functional team meetings, including preparing agendas and documenting meeting notes. Facilitate follow-up meetings in regard to action items previously identified
• Assist in project forecasting and effectively plan requirements for upcoming tasks
• Collaborate with process experts and production personnel to identify and resolve technical challenges
• Provide technical expertise and recommend process improvements
• Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols
• Perform additional tasks or duties as assigned by management

Requirements

• Bachelors’ degree in Engineering, Science, or a related field of study
• 2-5 years' experience validating GMP utility systems (WFI, Purified Water, clean steam, compressed air, HVAC) and associated instrumentation (e.g., Kaye Validators, temperature/humidity dataloggers)
• 2-5 years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and/or reports. Must be familiar with regulatory (FDA) requirements
• Advanced critical thinking and technical writing skills
• Strong organizational, communication, and interpersonal skills

Compensation and Benefits

• Expected pay range per year: $75,000-$95,000 USD
• Expected benefits include: Medical, Dental, Vision, PTO, 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.