Manufacturing Specialist Job at Argenta (Shawnee)

Job Responsibility

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
Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications
Perform the daily setup and routine operation of the packaging line, including, but not limited to: 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
Meet the production schedules outlined by line team and/or Supervision
Manage area cleaning requirements including facility, equipment, and Operational Excellence initiatives
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
Participate in Sterile Media Fill qualifications for Sterile Filling and maintenance activities
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.

Requirements

Previous experience using automated inventory system is required (i.e., SAP, MES, etc.)
Previous experience using motorized & non-motorized material handling equipment required
SAP or other Enterprise Resource Planning (ERP) experience highly desired
Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills required
Good written and verbal communication skills in English required
Good PC Skills, including use of e-mail, attaching documents to e-mail required
Previous experience using electronic databases and on-line tools required (i.e., but not limited to, Lotus Notes database, Employee Self-Services on-line tools, etc.)
Experience in a government regulated, Good Manufacturing Practices (GMP) or Standard Operating Procedures (SOP) environment preferred

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Manufacturing Specialist

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