Validation Engineer – Smoke Studies

Validation Engineer – Smoke Studies / Airflow Visualization

Company: Woodstock Sterile Solutions

Location: Woodstock, IL 60098

Contract Length: 6 months, with potential to extend

Pay Rate: $80–$100/hour, depending on experience

Schedule: 40 hours per week; eight-hour shifts starting between 6:00 and 7:00 a.m. Occasional overtime and Saturday work may be required.

Position Summary

Woodstock Sterile Solutions is seeking a hands-on Validation Engineer with specialized experience in smoke studies and airflow visualization to support a sterile manufacturing validation project.

Working alongside two other team members, you will execute and document smoke studies across 36 manufacturing suites, including multidose processing rooms, tip and cap assembly rooms, and single-dose manufacturing areas. The project includes evaluating airflow during manufacturing activities and the transfer of presterilized components into critical processing areas.The project includes evaluating airflow during manufacturing activities and the transfer of presterilized components into critical processing areas.

This position requires substantial time on the manufacturing floor, meticulous adherence to approved protocols, and the ability to interpret study results against current FDA expectations. At least two years of direct smoke study experience and experience supporting FDA inspections are required.

Key Responsibilities

• Execute airflow visualization studies in classified cleanrooms and aseptic processing areas according to approved protocols, site procedures, and project schedules.
• Support the preparation, review, and revision of smoke study protocols, test plans, acceptance criteria, and final reports.
• Evaluate airflow under static and dynamic conditions, including routine operations, operator movements, material transfers, and representative aseptic interventions.
• Assess airflow protection around exposed sterile components, product-contact surfaces, and critical processing locations.
• Identify and document airflow disruptions, turbulence, stagnant areas, or potential contamination pathways.
• Set up and operate smoke generation equipment and coordinate video recording to clearly capture study conditions and airflow patterns.
• Maintain complete, traceable study records, including video references, observations, discrepancies, and written conclusions.
• Promptly communicate unexpected results or protocol deviations and support investigations, corrective actions, and repeat studies when needed.
• Collaborate with Validation, Quality Assurance, Manufacturing, Engineering, and Microbiology to coordinate study execution and resolve findings.
• Support inspection readiness by organizing study documentation and explaining study methods, observations, and conclusions during FDA inspection activities.
• Follow aseptic practices, gowning requirements, cleanroom behavior standards, and safety procedures throughout study execution.
• Track assigned deliverables and communicate progress, scheduling needs, and potential delays.

Required Qualifications

• Minimum of two years of direct, hands-on experience executing smoke studies or airflow visualization studies in sterile pharmaceutical or comparable aseptic manufacturing environments.
• Recent practical experience with smoke study execution and a current understanding of FDA expectations for aseptic processing and airflow visualization.
• Experience supporting FDA inspections, including preparing, presenting, or explaining validation documentation.
• Experience evaluating airflow during dynamic operating conditions, including personnel activities, equipment operation, and component transfers.
• Ability to interpret airflow patterns and recognize conditions that could compromise protection of sterile products or components.
• Experience following approved validation protocols and preparing accurate, detailed GMP documentation.
• Familiarity with smoke generation equipment, study video recording, and review of recorded study evidence.
• Ability to complete required gowning qualification and work in classified aseptic areas using site-required gowning.
• Strong attention to detail, sound technical judgment, and clear written and verbal communication skills.
• Ability to work onsite full time and accommodate occasional overtime or Saturday work.

Preferred Qualifications

• Bachelor’s degree in Engineering, Microbiology, Pharmaceutical Sciences, or a related technical discipline, or equivalent relevant experience.
• Experience with blow-fill-seal (BFS) manufacturing, multidose products, single-dose containers, or tip and cap assembly operations.
• Experience assessing transfers of presterilized components into aseptic processing areas.
• Familiarity with cleanroom HVAC systems, HEPA filtration, unidirectional airflow, and contamination control principles.
• Experience with validation deviations, root cause investigations, CAPA, and change control.

Work Environment

This is a floor-based assignment in a sterile manufacturing facility. You must be comfortable working in full cleanroom gowning for extended periods, coordinating closely with production personnel, and following detailed protocols while meeting project deadlines.