Airflow Visualization & Asset Reliability Coordinator

About The JobThe 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 position serves as the subject‑matter expert 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 role 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 ResponsibilitiesAirflow Visualization & Contamination ControlServe 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 areasAseptic compounding suitesLAFWs, BSCs, and other critical processing equipmentEnsure 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 SystemServe as system administrator for the Blue Mountain RAM (BMRAM) platform across both sites.Harmonize asset management practices, including:Asset hierarchies and naming conventionsEquipment criticality classificationsPreventive maintenanceEnsure 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 & GovernanceCoordinate 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 SupportSupport 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.Basic QualificationsBachelor'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 expectations21 CFR Parts 210/211ISO 14644USP 797 & 800Ability 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.What's on OfferWe offer a dynamic environment where talent and ambition can develop to its fullest. Our open and informal organization culture encourages strong motivation and independent work. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. This job includes competitive salary, comprehensive benefits, performance package, and the chance to be part of an international leader in an expanding industry.EEO StatementFagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.#J-18808-Ljbffr