Sr. Manager, Media Fill
Core
Lead the site-wide aseptic process simulation (media fill) program and equipment requalification to ensure sterility assurance and regulatory compliance for sterile manufacturing.
Role type
Senior Manager, Aseptic Process Simulation & Requalification
Builds
Sterile manufacturing operations for pharmaceutical and biotech customers
Domain
Pharmaceutical/Biotech manufacturing, Aseptic processing, GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing expertise, Contamination control strategy (CCS), GMP compliance, Regulatory inspection readiness, Root cause analysis, CAPA execution, Team leadership, Resource planning
Preferred skills
Advanced degree (MS/PhD), CDMO experience, Client-facing environment experience, TrackWise/SAP/MES systems knowledge
Technologies
TrackWise, SAP, MES
Responsibilities
Lead media fill and requalification programs, Ensure FDA/EMA/Annex 1 compliance, Partner with Quality/Manufacturing/Engineering teams, Lead investigations into failures and deviations, Serve as SME during audits, Drive continuous improvement initiatives, Define resource needs for sterile manufacturing
Seniority
Senior, hands-on IC with leadership responsibilities
