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 (Physical/Clinical work)
Builds
Validated aseptic manufacturing processes
Domain
Pharmaceutical/Biotech, Sterile Manufacturing
Deliverable
physical/clinical work
Required skills
aseptic processing, media fill execution, cGMP compliance, validation protocols, risk assessment, technical writing, contamination control
Preferred skills
cross-functional partnership, continuous improvement, complex project leadership
Technologies
None stated
Responsibilities
Lead design and execution of media fill studies, author and review validation protocols and reports, support investigations and deviations, partner with Manufacturing/Quality/Regulatory teams, ensure regulatory compliance, drive contamination control improvements
Seniority
Staff, hands-on IC