Lead GMP 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

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