Aseptic Process Mentor (Weekend)
Core
Monitor aseptic core operations to ensure GMP compliance and mentor operators on aseptic techniques during filling and lyophilizer loading.
Role type
Aseptic Process Mentor (Weekend)
Builds
Pharmaceutical manufacturing products (filling and lyophilization)
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic gowning proficiency, visual auditing of aseptic behavior, corrective action training, media fill documentation review, trend analysis, GMP compliance knowledge
Preferred skills
Bachelor's in Microbiology or Life Sciences, experience as Aseptic Control Operator and qualified trainer
Technologies
Lyophilizers, filling equipment
Responsibilities
Monitor Filling Operators by completing daily visual audits of Aseptic Behavior inside the core during fills and lyophilizer loading; Take immediate action when non-compliance and/or undesired behavior by personnel in the complex is observed; Partner with Production/Quality/Training Leadership to make recommendations for enhancements to aseptic process; Provide corrective action training based on visual audit by immediate feedback; Complete daily inspections of the physical conditions of the aseptic core; Review aseptic technique associated with media fills and help complete documentation and final vial count verification; Provide escort of non-gown qualified individuals on an as needed basis; Reports metrics and trends to site management on a regular basis.
Seniority
Mid-level, hands-on IC
