RTP SA Technician (June 2026)

Overview Client is seeking a Sterility Assurance Technician to support aseptic manufacturing operations within their parenteral manufacturing facility. This individual will serve as an extension of the Sterility Assurance team on the manufacturing floor, partnering closely with Operations and Environmental Monitoring to ensure aseptic practices, sterility assurance, and bioburden control are maintained during production activities. The role is highly floor-facing and will spend the majority of the shift coaching operators, auditing behaviors, supporting investigations, and responding to unplanned events in classified manufacturing environments. Day-to-Day Responsibilities Serve as Sterility Assurance presence within aseptic manufacturing operations Coach, audit, and reinforce proper aseptic techniques during production activities Monitor manufacturing activities and identify risks to aseptic conditions Lead and support remediation activities related to manufacturing events Partner with Operations regarding aseptic behaviors and best practices Conduct internal audits and procedural compliance reviews Support deviation investigations and execute required studies Assist with qualification and validation activities supporting sterility assurance and bioburden control Analyze manufacturing data and recommend compliant solutions Act as a technical resource for sterility assurance questions and issues Support smoke studies and other aseptic qualification activities Maintain strong safety and GMP compliance standards Must-Have Experience Minimum 2+ years supporting pharmaceutical cGMP manufacturing Experience within parenteral drug product manufacturing Strong aseptic processing background Experience supporting filling, formulation, and/or isolator operations Ability to work directly in classified cleanroom environments Strong understanding of GMP documentation and compliance Comfortable coaching and correcting aseptic behaviors on the manufacturing floor Nice-to-Have Experience Environmental Monitoring Microbiology Equipment Qualification Validation Deviation investigations Change controls TrackWise Kneat Smoke studies Bioburden control programs #J-18808-Ljbffr Medasource