Utility Validation Engineer

Stark Pharma Solutions Inc; Chicago (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Utility Validation Engineer to support validation activities for GMP utility systems in a Chicago-area, Illinois manufacturing environment.

The role emphasizes leading qualification efforts, preparing validation documentation, and collaborating with Engineering, Quality, Manufacturing, and other cross-functional teams to ensure cGMP and FDA compliance. The position requires a Bachelor’s degree in Engineering or Science and 2–5 years of GMP utility

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 2–5 years GMP utility validation or qualification experience.
• Experience with WFI, Purified Water, clean steam, HVAC systems.
• Experience with Kaye Validators and temperature/humidity data loggers.
• Knowledge of FDA regulatory requirements and cGMP standards.

Responsibilities

• Author URS, RA, and FS documents.
• Lead commissioning testing for GMP utility systems.
• Develop and execute IQ/OQ/PQ qualification protocols.
• Lead qualification of WFI, Purified Water, and HVAC systems.
• Coordinate cross-functional meetings and document action items.
• Support project forecasting and planning for upcoming qualification activities.
• Maintain compliance with cGMP and FDA requirements.

Skills

GMP validation experience

cGMP compliance

Technical writing

Cross-functional collaboration

Validation documentation

Education

Bachelor's degree in Engineering/Science

Tools

Kaye Validators

Data loggers

Job description

Job Overview

We are seeking a Utility Validation Engineer to support utility system validation and qualification activities in a GMP manufacturing environment. The role involves leading qualification activities, preparing validation documentation, supporting commissioning, and collaborating with Engineering, Quality, Manufacturing, and other cross-functional teams to ensure compliance with cGMP and FDA requirements.

Position

Utility Validation Engineer

Location

Illinois

Duration

Long Term

Key Responsibilities

• Author specifications and supporting documentation, including URS, RA, and FS.
• Lead commissioning testing for GMP utility systems.
• Develop and execute IQ/OQ/PQ qualification protocols.
• Support qualification of WFI and Purified Water systems.
• Lead qualification of clean steam, compressed air, and process gas systems.
• Perform temperature mapping and airflow/smoke studies for HVAC and cleanroom qualification.
• Use Kaye Validators and temperature/humidity data loggers for qualification activities.
• Manage multiple qualification activities, schedules, and deliverables.
• Lead cross-functional meetings and document meeting notes and action items.
• Support project forecasting and planning for upcoming qualification activities.
• Collaborate with Engineering, Process, and Production teams to resolve technical issues.
• Provide technical expertise and recommend process improvements.
• Maintain compliance with cGMP, FDA requirements, company policies, and safety procedures.

Required Qualifications

• Bachelor s degree in Engineering, Science, or a related field.
• 2 5 years of experience in GMP utility validation or qualification.
• Experience with WFI, Purified Water, clean steam, compressed air, and HVAC systems.
• Experience with Kaye Validators and temperature/humidity data loggers.
• Experience working in a GMP manufacturing environment.
• Experience preparing SOPs, validation protocols, and technical reports.
• Knowledge of FDA regulatory requirements and cGMP standards.
• Strong critical-thinking and technical-writing skills.
• Strong communication, organizational, and cross-functional collaboration skills.