Lead GMP Utility Validation Engineer

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

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting seeks a motivated professional to lead utility system validation and qualification in a GMP manufacturing environment. This mid-level role drives projects from planning through execution and partners with Engineering and Process experts to ensure compliance with FDA cGMP standards.

The successful candidate will develop IQ/OQ/PQ protocols for WFI, Purified Water, HVAC, and related systems, perform temperature mapping and airflow studies, and lead cross-functional meetings to keep

Qualifications

• 2–5 years validating GMP utility systems (WFI, Purified Water, clean steam, HVAC).
• 2–5 years in GMP manufacturing; drafting SOPs, protocols, and/or reports.
• Advanced critical thinking and technical writing skills.
• Strong organizational, communication, 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 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.

Skills

GMP utilities

Instrumentation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, or a related field

Tools

Kaye Validators

Dataloggers

Job description

cGMP Consulting seeks a motivated professional to lead utility system validation and qualification in a GMP manufacturing environment. This mid-level role drives projects from planning through execution and partners with Engineering and Process experts to ensure compliance with FDA cGMP standards.

The successful candidate will develop IQ/OQ/PQ protocols for WFI, Purified Water, HVAC, and related systems, perform temperature mapping and airflow studies, and lead cross-functional meetings to keep