Validation Specialist

AVS Specialist (Validation)

Contract- 6 Months +

Tampa, FL (On-Site)

Overview

We are seeking an experienced AVS (smoke study) specialist to develop and execute air visualization studies for aseptic filling and compounding processes at a sterile manufacturing site. The role works hands-on with internal validation and manufacturing teams and with third-party study vendors.

Responsibilities

• Develop AVS protocols for filling lines, compounding areas, isolators/RABS, and associated cleanrooms
• Define study scope, including static and dynamic conditions, first-air paths, critical interventions, and operator activities
• Lead and participate in study execution alongside third-party AVS vendors
• Review video recordings and assess airflow patterns for turbulence, reflux, and stagnant zones
• Author study reports documenting findings, deviations, and recommended corrective actions
• Support links to aseptic process simulation (media fill), environmental monitoring, and the contamination control strategy
• Collaborate with Validation, Quality, Engineering, and Manufacturing to resolve findings and support CAPAs
• Support regulatory inspection readiness and responses related to airflow and aseptic practices

Requirements

• Bachelor’s degree in engineering, microbiology, or a related life science
• 5+ years in sterile/aseptic pharmaceutical manufacturing, with direct AVS/smoke study experience
• Hands-on experience with aseptic filling lines and compounding operations
• Working knowledge of EU GMP Annex 1, FDA Guidance on Sterile Drug Products Produced by Aseptic Processing (2004), and ISO 14644
• Experience managing third-party vendors during study execution
• Strong technical writing skills for protocols, reports, and deviations

Preferred

• Experience with isolator or RABS filling lines
• Familiarity with remediation efforts responding to FDA warning letters or 483 observations
• Background in cleanroom qualification or HVAC/airflow validation

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