Validation Specialist

Job Description

Job Description

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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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