Manufacturing Operator - 1st shift

Manufacturing Specialist – Shawnee, KS

Argenta is currently looking to fill the role Manufacturing Specialist at our Shawnee, KS location.

• Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines.
• Perform equipment setup and changeover activities. Act to safely reduce equipment setup and changeover times.
• Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications. Meet line Operational Asset Effectiveness requirements per area targets. Ensure downtime is escalated properly.
• Perform the daily setup and routine operation of the packaging line, including bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained.
• Perform preventive maintenance tasks as needed and trained.
• Troubleshoot Variable Frequency Drives and Servo Drive systems as trained.
• Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions.
• Palletize both finished and unfinished products and operate motorized and non-motorized material handling equipment.
• Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.
• Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e., training team members, motivating and supporting team members, sharing knowledge to continuously improve the process, etc.).
• Meet the production schedules outlined by line team and/or Supervision. Review and approve work output for team members by using validated methods.
• Manage area cleaning requirements including facility, equipment, and Operational Excellence initiatives.
• Area Specific Responsibilities:
  • Weigh/Dispense – Manage Material movement functionalities and dispensing of materials for planned batches.
  • Solid Dose Compounding – Manage Solids Compounding Operation that includes CIP, EQ Setup, Raw Material Additions, and general process steps. Manage Batch control system recipe operations.
  • Liquids Compounding – Manage Liquids Compounding Operations that include CIP, SIP, Equipment Setup, Raw Material Additions, and general process steps. Manage Batch Control System Recipe Operations.
  • Sterile Filling – Perform the functions required for the Bio-Class I clean room. Sterile filling and sterile filtration of all sterile drug solution products from bulk into final containers. This position will also include running the autoclave, terminal sterilizer, preparation of filling equipment and components, and maintaining area logbooks and housekeeping procedures. Includes monitoring, troubleshooting, and training for activities of filtration, and filling preparation which include basic understanding of MMI (Man Machine Interface) Systems, CIP (Clean In Place) Systems and SIP (Steam In Place) processes.
    
    Participate in Sterile Media Fill qualifications for Sterile Filling and maintenance activities. This is a critical qualification for duties performed in the sterile core. Disassemble, clean, reassemble, and prepare all sterile filling product contact equipment and supplies for sterilization.
  • Filling and Packaging – Perform line start-up to ensure the proper drug products, labels, and components are used in the filling/packaging process. Manage filling and packaging operations with the ability to run all equipment in the area including filler, cartoner, labeler, bundler, etc. Must be proficient enough to train other operators.