Airflow Visualization & Asset Reliability Coordinator

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13551346

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