Dynamic individual with hands-on experience in GCMP and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.
· Maintain work areas and performing job functions in a safe and efficient manner in accordance with policies and procedures, Good Manufacturing Practices (cGMP's), GDPs, and Batch Record instructions
· Cleaning facilities, equipment and sterile tools as required following SOP's and WI's.
· Mixed buffers and solutions to support upstream and downstream drug productions.
· Set up, changeover, program and operate various equipment such as Toledo floor scale, tabletops, 50-200L SUM, PH meter and Osmolarity meters, Palltronic Filter integrity tester, Glove Integrity tester. Skann Isolater. VHP, Sara In/out for pharmaceutical drug production fill.
· Aseptic/Environmental Monitoring qualified. Operated Lasair, SAS air sampler, using rodac plates for personal and surface monitoring.
· Qualified in various equipment such as Belimed/Getinge Autoclaves, DeltaV systems, biosafety cabinets, and aseptic connections using AQG, MPX, and Kleenpack sterile connectors, clean room V+ gowning in/out procedures.
· Prepare manufacturing areas and equipment, operated Skann Isolater. VHP, Sara In/out, setup tools and materials for pharmaceutical drug production fill.
· Complete documentation as required in the manufacturing, filling and/or packaging of products
· Maintains accurate, neat, error free records such as batch records, logbooks, and SAP
· Maintain a culture of safety first, identifying near misses, safety walkthroughs and 5s. Ensure chemicals are properly stored and labeled.