Fagron Sterile Services US (FSS) · 1 day ago
Airflow Visualization & Asset Reliability Coordinator
Wichita, KS
Full-time
Onsite
Entry, Mid Level
2+ years expFagron Sterile Services US is the global market leader in pharmaceutical medicine, aiming to improve medications and help patients. The Airflow Visualization & Asset Reliability Coordinator is responsible for overseeing airflow visualization programs and asset reliability governance across outsourcing facilities, ensuring compliance with FDA regulations and quality standards.
Health CareMedicalPharmaceutical
Responsibilities
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
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
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
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
Qualification
Required
Bachelor's degree or equivalent combination of education and experience
Minimum of 2 years of experience in sterile pharmaceutical manufacturing or 503B outsourcing facility operations
Familiarity with airflow visualization (smoke study) concepts in aseptic environments
Experience with CMMS platforms supporting asset management
Knowledge of applicable regulations and guidance, including: FDA 503B cGMP expectations, 21 CFR Parts 210/211, ISO 14644, USP 797 & 800
Ability to travel between Wichita, KS and Canton, MA as required
Strong understanding of aseptic processing and contamination control in 503B outsourcing facilities
Knowledge of cleanroom airflow principles, HVAC fundamentals, and airflow visualization interpretation
Familiarity with regulated asset management or CMMS platform (Blue Mountain RAM strongly preferred)
Strong risk-based decision-making and technical judgment skills
Ability to harmonize practices across geographically separated sites
High level of inspection readiness, with confidence interfacing directly with FDA investigators
Ability to work with diverse teams focusing on common goals
Strong written and verbal communication skills, particularly for technical and regulatory audiences
Benefits
Competitive salary
Comprehensive benefits
Performance package
Company
Fagron Sterile Services US (FSS)
Fagron Sterile Services US operates two cGMP compliant DEA/FDA-registered and inspected 503B Outsourcing Facilities (Wichita, KS & Boston, MA) delivering a reliable supply sterile of medications to patient-focused healthcare facilities across the United States.
201-500 employees
H1B Sponsorship
Fagron Sterile Services US (FSS) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Angels for Change
2025-05-29Grant
2023-09-07Grant
Leadership Team
Gwen Bosch
Talent Acquisition and Development Partner
William Patti
HR Business Partner
Recent News
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