Operates & monitors biopharmaceutical production equipment & purification processes, in accordance to procedures/batch records. Executes filtration processes, viral inactivation, process chromatography and aseptic operations in accordance to SOP.
Weighs and measures raw materials, and prepares buffer solutions for use in batch manufacturing.
Performs equipment/sanitary parts CIP/COP (Clean In Place/Clean out of Place) and assists with production equipment inspections, maintenance, assembly and disassembly.
Operates & standardizes analytical instruments including pH meters, conductivity meters, flow meters, spectrophotometers, integrity testers in accordance to Standard Operating Procedures (SOP's),
Completes production records and documentation with strict adherence to Good Manufacturing Practices (cGMP's) and Good Documentation Practices. Maintains equipment logbooks, reviews & files documentation.
Supports revisions of standard operating procedures, and assists in completion dept. non-compliance investigations (deviations), and execution of change controls.