at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
About the Job
The Airflow Visualization & Asset Reliability Coordinator is the site-spanning technical owner for airflow visualization (smoke study) programs and asset reliability system governance across FSS outsourcing facilities in Wichita, KS and Canton, MA. This role provides oversight, technical assistance, and harmonization of practices to ensure consistent, compliant execution of airflow visualization studies and asset lifecycle management in accordance with FDA 503B expectations, cGMP principles, and internal quality systems.
The role serves as the subject matter expert (SME) for airflow visualization and the system owner for the Blue Mountain RAM (BMRAM) platform, ensuring standardized asset hierarchies, PM/calibration strategies, and data integrity across both sites. The position interfaces with Operations, Quality Assurance, Engineering/Maintenance, and plays a key role in inspection readiness, contamination control strategy (CCS) execution, and continuous improvement initiatives.
Key Responsibilities
Airflow Visualization & Contamination Control
- Serve as the enterprise SME for airflow visualization (smoke studies) across 503B sterile compounding operations.
- Establish, harmonize, and maintain standardized airflow visualization practices, acceptance criteria, and documentation approaches across Wichita and Canton sites.
- Plan, schedule, and oversee airflow visualization studies for:
- ISO-classified cleanrooms and support areas
- Aseptic compounding suites
- LAFWs, BSCs, and other critical processing equipment
- Ensure studies are executed under representative operating conditions, including routine and worst-case personnel, equipment configurations, and interventions.
- Evaluate airflow patterns for unidirectional flow, turbulence, airflow shadowing, and recovery following dynamic activities.
Asset Reliability & BMRAM System
- Serve as system administrator for the Blue Mountain RAM (BMRAM) platform across both sites.
- Harmonize asset management practices, including:
- Asset hierarchies and naming conventions
- Equipment criticality classifications
- Preventive maintenance
- Ensure consistent, compliant configuration of PMs, inspections, and work order workflows.
- Partner with Engineering, Maintenance, and Quality to ensure asset lifecycle activities support validated and qualified states.
- Oversee user access, audit trails, and data integrity controls.
- Drive continuous improvement initiatives (PM augmentations) using asset performance and reliability data.
Cross-Site Harmonization & Governance
- Coordinate cross-functional alignment between Wichita and Canton to ensure consistent interpretation and execution of airflow and asset reliability requirements.
- Develop and maintain standard work, SOPs, and guidance documents applicable to both sites.
- Support site-specific deviations, CAPAs, and change controls related to airflow performance, HVAC impacts, or asset reliability.
- Provide training to Operations, Quality, and Maintenance personnel on airflow visualization expectations and BMRAM workflows.
Inspection Readiness & Quality System Support
- Support FDA inspections, state inspections, and customer audits related to contamination control and asset management.
- Provide clear, defensible explanations linking airflow visualization results and asset controls to patient safety and product quality.
- Contribute to site contamination control strategies (CCS), aseptic process evaluations, environmental monitoring program support.
- Partner with Quality to identify trends, risks, and improvement opportunities
