Utility Validation Engineer
$75,000–$95,000 year
On-siteMelrose Park, Illinois, United States
Job Summary
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. 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.
Required Qualifications
- 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.
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