Staff Validation Engineer, Media Fills
Core
Lead the design and execution of media fill (aseptic process simulation) studies to ensure sterile manufacturing processes remain validated and compliant with global regulatory expectations.
Role type
Staff Validation Engineer (Media Fills)
Builds
Validated aseptic manufacturing processes
Domain
Pharmaceutical/Biotech, Sterile Manufacturing
Required skills
aseptic process simulation, validation protocol design, risk assessment, deviation investigation, CAPA management, cGMP compliance, technical writing, contamination control
Preferred skills
cross-functional partnership, continuous improvement strategies
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