Aseptic Process Simulation Program Coordinator
Core
Lead the site-wide Aseptic Process Simulation (APS/Media Fill) program to ensure compliance with GMP, FDA, and EU Annex 1 standards for sterile ophthalmic manufacturing.
Role type
Senior Program Lead, Aseptic Process Simulation
Builds
Sterile ophthalmic manufacturing operations
Domain
Pharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, FDA/EU Annex 1 regulations, aseptic process simulation design, root cause analysis, CAPA management, trend analysis, cross-functional collaboration, protocol authoring, regulatory inspection readiness, continuous improvement
Preferred skills
MBA, strategic planning, project management, technical leadership, mentorship, industry trend monitoring
Technologies
Program management communication software, business financial systems
Responsibilities
Develop and execute annual media fill strategy, serve as SME for investigations and inspection readiness, collaborate with Manufacturing/Quality/Microbiology/Engineering/Validation teams, author and approve APS protocols and risk assessments, lead investigations and CAPA for media fill failures, analyze APS performance metrics, ensure personnel qualification integration, support regulatory inspections and customer audits, drive continuous improvement initiatives
Seniority
Senior, hands-on IC with leadership focus