Lead GMP Utility Systems 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

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