Reagent Bulk & Fill Technician IV
San Diego, CA - USA
Job Summary
Title: Reagent Bulk & Fill Technician IV (Variable Shift)
Location: San Diego CA 92127
Duration: 7 months (extension likely)
Location: San Diego CA 92127
Duration: 7 months (extension likely)
40 hrs/week Variable shifts (1st 2nd 3rd weekends as needed)
Morning (6am to 2.30 pm) OR Afternoon (2pm to 10.30pm)
Summary:
Senior manufacturing technician responsible for bulk reagent formulation and automated filling operations supporting clinical/commercial diagnostic kits including aliquoting packaging in process inspection sampling for QC/bioburden and strict cGMP documentation.
Senior manufacturing technician responsible for bulk reagent formulation and automated filling operations supporting clinical/commercial diagnostic kits including aliquoting packaging in process inspection sampling for QC/bioburden and strict cGMP documentation.
Key Requirements:
- Manufacture bulk reagents: raw material staging weighing/measuring formulation bulking/filling/aliquoting/packaging
- Operate/lead setup changeover and troubleshooting of automated fill equipment (independently run majority of machines)
- Strong documentation: DHR completion/review logbooks training records; update SOP/DMR documents
- Systems: perform transactions in SAP/ERP (materials consumption labor sampling labeling)
- Quality: support QN investigations CAPA feedback audit readiness; demonstrate processes in FDA/ISO/internal audits
- Material handling for temperature sensitive semi-finished goods (blood screening kits) visual inspection and sampling
- Lead/support cycle counts KPI reporting; mentor/train junior techs; maintain housekeeping and safety compliance
- Flexibility: variable shifts weekends; adjust PTO around plant shutdowns (Aug 2026 and late Dec 2026)
- Education: HS/GED required; Associate degree preferred
- Training/Compliance: GMP/GDP/ISO knowledge; Blood Borne Pathogen training noted