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LFB USA, Inc.

LFB USA, Inc. is hiring: Manufacturing Technician II-2 in Charlton

LFB USA, Inc., Charlton, MA, United States


SPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS)Operates & monitors production equipment, in accordance to procedures/batch records (with minimal senior operator/supervisor/manager oversight); including process tanks, balances, bioburden filtration assemblies, chromatography columns/skids, UF/DF equipment, data recorders and depth filter systems.Demonstrates practical/theoretical knowledge of biomanufacturing concepts and cGMP.Weights and measures raw materials, and prepares buffer solutions for use in bulk manufacturing.Performs equipment sanitary parts CIP/COP (Clean In Place/Clean out of Place) and assists with production equipment maintenance, assembly and disassembly.Performs aseptic operations including equipment in-process sampling and work in Laminar Flow Hoods/Biosafety Cabinets, under guidance of senior operator/supervisor.Disinfects/cleans cleanroom/facility and maintains plant consumable/inventory levels.Operates & standardizes analytical instruments including pH meters, conductivity meters, flow meters, spectrophotometers, integrity testers in accordance to Standard Operating Procedures (SOP's), with no supervision.Completes production records and documentation with strict adherence to Good Manufacturing Practices (cGMP's) and Good Documentation Practices.Maintains equipment logbooks, reviews & files documentation Assists in Validation/Engineering and Calibration activities with senior operator/supervisor guidance.Practices safe work habits and adheres to company safety procedures and guidelines.Maintains "current" status on pertinent standard operating procedures including in training curriculum, via EQMS/documented training Supports revisions of standard operating procedures, and assists in completion dept. non-compliance investigations (deviations), and execution of change controls.Works in cleanroom environment, and performs work duties in accordance to aseptic technique concepts/proper cleanroom (and gowning) protocol.Prepares facility/equipment and consumables based on established schedules.Executes facility inspection walkthroughs and communicates safety/contamination/repair issues/needs. Proiects/development opportunities are provided based on employee development goals.