Pharmaceutical Technician I-Iii
Frederick, Maryland, United States
● Subject-matter expert of the manufacturing execution system Pas-X, used to process our electronic batch records.● Subject-matter expert for SAP. ● Performs functions to clean and sterilize buffer hold tanks, as well as manage the transfer of buffer solution to hold tanks, following our Standard Operating Procedures (SOPs) and keeping with Good Manufacturing Practices (cGMPs). ● Operates General Electric AxiChrom Columns, Conditioning Skid, Media Handling Unit, Slurry Tank and Master Packing Unit to perform Column Packing, Unpacking, and HETP testing. ● Advanced equipment and process knowledge to perform first-line troubleshooting and root cause analysis during process equipment and procedure failure investigations to identify corrective and preventive actions to close out deviations. ● Qualified on operating MFF skids, chromatography skids, viral filtration skids, and UFDF skids to provide downstream processing and formulation of harvested material. ● Operates and maintains Solo VPE Unit to determine protein concentration of product. ● Calibrates and standardize online and offline conductivity, UV, and pH meters. ● Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. ● Ensures team members comply with safety rules and regulations and ensures all safety related incidents are reported to supervisor/Safety Health and Environment Team. ● Completes manufacturing documentation per approved procedures. Reviews documentation for completeness and accuracy per established timelines. ● Trains entry and junior level technicians in Downstream Operations. ● Promotes a "Lean Culture" by looking for ways to make our systems and processes more cost-effective and efficient by executing 8 wastes projects, continuous improvement projects, one-point lessons, and level 0 problem solving’s. ● Repeatedly recognized for top performance through promotion and performance review.