Staff Validation Engineer, Media Fills
Core
Leading media fill (aseptic process simulation) programs to support sterile/aseptic manufacturing operations and ensure regulatory compliance.
Role type
Staff Validation Engineer (Media Fills)
Builds
Validated aseptic manufacturing processes
Domain
Pharmaceutical/Biotech, Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aseptic process simulation, validation protocol design, risk assessment, deviation investigation, CAPA management, cGMP compliance, technical writing, contamination control strategies
Preferred skills
cross-functional partnership, continuous improvement initiatives
Technologies
GMP, FDA, EMA regulations
Responsibilities
Lead design and execution of media fill studies, author and review validation protocols and reports, support investigations and CAPAs, ensure compliance with global regulatory requirements, drive continuous improvement in validation strategies
Seniority
Staff, hands-on IC
